MicroVention IFU100137 Hydro Pearl Micros Pheres Instructions

MicroVention IFU100137 Hydro Pearl Micros Pheres

Product Information

Specifications

• MR Compatibility: MR Safe
• Material: Polyethylene glycol diacrylamide, Glycerol monomethacrylate, Dye Colorant

Size Range: Microparticle Size

• Orange Yellow Blue
• Red Green Purple

Material Information Limits:

Product Usage Instructions

1. Description
   The HydroPearl Microspheres are designed for controlled, targeted embolization. They are pre-formed, compressible, calibrated, spherical, and biocompatible microspheres made using Poly-Ethylene Glycol.

2. Intended Purpose/Indications
   The HydroPearl Microspheres are intended to occlude blood vessels for therapeutic purposes in various conditions including hypervascularized carcinoma, hepatocellular carcinoma, uterine fibroids, benign prostatic hyperplasia, and more.

3. Clinical Applications
   The product has been extensively documented for embolization procedures in neurological and peripheral vascular systems including various body parts like the head, neck, spine, liver, genitourinary tract, and limbs.

4. Warnings/Precautions/Complications
   Users should report any serious incidents to the manufacturer and competent authorities. Vascular embolization is a high-risk procedure that should be performed by trained physicians. Complications may include undesirable reflux, embolization of wrong arteries, radiation burns, risks to fertility, and more.

FAQ

Q: What are the specific contraindications for the HydroPearl Microspheres?
A: Specific contraindications include use in vertebral artery or intra-cranial vasculature and certain vessels listed in the manual.

HydroPearl™ Microspheres Instructions for Use
STERILE – SINGLE USE ONLY – NON-PYROGENIC
MR Compatibility: MR Safe
Please read all instructions carefully prior to use.

DESCRIPTION

HydroPearl Microspheres are part of a family of embolic materials based on MicroVention’s proprietary microsphere technology. These spheres are designed to offer controlled, targeted embolization. HydroPearl Microspheres are made using Poly-Ethylene Glycol and comprises of a range of microspheres that are pre-formed, compressible, calibrated, spherical and biocompatible. HydroPearl Microspheres are available in the following size range:

Qualitative and Quantitative Material Information

Substance and/or Material| Limit
Polyethylene glycol diacrylamide| ≤ 25 ppm
Glycerol monomethacrylate| ≤ 15 ppm
Dye Colorant| ≤ 10 ppm
Other residual solvent| ≤ 10 ppm

PRESENTATION

• HydroPearl Microspheres are contained in a sterile 20ml pre-filled syringe and packaged in a pre-formed tray with Tyvek peel-away lid.
• Each syringe contains approximately 2 ml of HydroPearl Microspheres in non-pyrogenic, sterile, transport solution of physiological buffered saline.
• The product is sterilized by steam. Do not use if the unit package is opened or damaged.
• Each syringe is intended for a single patient use only. Do not re-sterilize. Discard any unused material.
• Permanent implant. Follow-up required at the discretion of the physician.

INTENDED PURPOSE/INDICATIONS:
The HydroPearl Microspheres are intended to occlude blood vessels for therapeutic and adjunctive purposes in hypervascularized carcinoma, hepatocellular carcinoma, uterine fibroids, benign prostatic hyperplasia, peripheral arteriovenous malformations, tumors of the neck, torso and skeletal system, bleeding and trauma and pre-operative reduction of bleeding.

CLINICAL APPLICATIONS:
The scientific literature provides extensive documentation of embolization procedures using a wide variety of artificial agents in both neurological and peripheral vascular systems, including the head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal system, limbs and lungs.

CONTRAINDICATIONS

• Targeted embolization of blood vessels belonging to the central vascular system (pulmonary arteries, ascending aorta, aortic arch, descending aorta to the aortic bifurcation, coronary arteries, common carotid artery, external carotid artery, internal carotid artery, cerebral arteries, brachiocephalic artery, cardiac veins, pulmonary veins, superior vena cava, inferior vena cava)
• Presence of any vasculature where spheres could pass directly into the central nervous system.
• Patients intolerant to occlusion procedures
• Vascular anatomy or blood flow that precludes catheter placement of embolic agent injection
• Presence or likely onset of vasospasm
• Presence or likely onset of hemorrhage
• Presence of severe atheromatous disease
• Presence of feeding arteries smaller than distal branches from which they emerge
• Presence of collateral vessel pathways potentially endangering normal territories during embolization
• Presence of arteries supplying the lesion not large enough to accept HydroPearl Microspheres
• Vascular resistance peripheral to the feeding arteries precluding passage of HydroPearl Microspheres into the lesion
• In large diameter arteriovenous malformations (i.e. where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to vein)
• In the pulmonary vasculature
• Patients with known allergies to radio-opaque contrast
• Pregnant patients

Uterine Fibroid Embolization (UFE) SPECIFIC CONTRAINDICATIONS:

• Pregnant women
• Suspected pelvic inflammatory disease or any other active pelvic infection
• Any malignancy of the pelvic region
• Endometrial neoplasia or hyperplasia
• Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity
• Presence of pedunculated serosal fibroid as the dominant fibroid(s)
• Fibroids with significant collateral feeding by vessels other than the uterine arteries

SPECIFIC CONTRAINDICATIONS: NEUROLOGICAL

• Presence of patent extra-to-intracranial anastomoses or shunts
• Presence of end arteries leading to cranial nerves
• In any vasculature where HydroPearl Microspheres could pass directly into the internal carotid, vertebral artery or intra-cranial vasculature or the above listed vessels.

WARNINGS / PRECAUTIONS / POTENTIAL COMPLICATIONS

Users and/or patients should report any serious incidents to the manufacturer and the Competent Authority of the Member State or Local Health Authority in which the user and/or patient is established.

COMPLICATIONS :
Vascular embolization is a high risk procedure. The procedure should be performed by physicians trained in vascular embolization procedures. Complications can occur at any time during or after the procedure and may include, but not limited to:

• Undesirable reflux or passage of HydroPearl Microspheres into normal arteries adjacent to the targeted lesion or through the lesion into other arterial beds or arteries.
• Embolization of the wrong artery or migration of the microspheres to the other parts of the body, which may necessitate further treatment.
• Hematoma, or bruising, at the incision site for arterial access
• Arterial aneurysm at the incision site for arterial access
• Deep vein thrombosis, or clotting of a deep vein in patient(s) leg
• Pulmonary embolization
• Ischemia at an undesired location
• Capillary bed saturation and tissue damage
• Vessel or lesion rupture and hemorrhage
• Neurological deficits including cranial nerve palsies
• Vasospasm
• Recanalization
• Foreign body reactions necessitating medical intervention
• Infection necessitating medical intervention
• Clot formation at the tip of the catheter and subsequent dislodgement
• Allergic reaction
• Risks of radiation from angiography and fluoroscopy used to visualize blood vessels during embolization, which may include radiation burn and risks to future fertility
• Death
• For gynecological embolizations, including fibroid embolization, risks include expulsion of a fibroid tumor or embolization materials from the uterus through vagina after procedure, amenorrhea following the procedure, worsening of fibroid-related symptoms or the onset of new symptoms, premature menopause, infection of the endometrium or other structures in the pelvis, which, if severe, could require a hysterectomy, and rupture of the uterus.

WARNINGS:

• Do not use HydroPearl Microspheres in conjunction with other embolization devices based on organic solvents such as ethyl alcohol or dimethyl sulfoxide (DMSO), at the same embolization site.
• There is no long-term data on the effect of UFE on the ability to become pregnant and carry a fetus to term, and on the development of the fetus.
• This procedure should only be performed on women who do not intend future pregnancy.
• Women who become pregnant following UFE may be at increased risk for the following:
  • Postpartum hemorrhage
  • Preterm delivery
  • Caesarean delivery
  • Malpresentation
• De-vascularization of the uterine myometrium resulting from UFE may increase the risk of uterine rupture of women who subsequently become pregnant following UFE.

UFE SPECIFIC POTENTIAL COMPLICATIONS

Potential post procedure complications include:

• Abdominal pain
• Discomfort
• Fever
• Nausea
• Constipation
• Premature ovarian failure (i.e. menopause)
• Amenorrhea
• Infection of the pelvic region
• Uterine/ovarian necrosis
• Phlebitis
• Deep vein thrombosis with or without pulmonary embolism
• Vaginal discharge
• Tissue passage, fibroid sloughing, or fibroid expulsion post UFE
• Post-UFE intervention to remove necrotic fibroid tissue
• Vagal reaction
• Transient hypertensive episode
• Hysterectomy

OTHER UFE WARNING:

• When using HydroPearl Microspheres for uterine fibroid embolization, do not use beads smaller than 500 microns.
• An appropriate gynecologic work-up should be performed on all patients presenting for embolization of uterine fibroids (e.g. gynecologic history, fibroid imaging, and endometrial sampling to rule out carcinoma in patients with abnormal menstrual bleeding).
• The diagnosis of uterine sarcoma could be delayed by taking a non-surgical approach (such as UFE) to treating fibroids. It is important to pay close attention to warning signs for sarcoma (e.g., rapid tumor growth, postmenopausal with new enlargement, MRI findings) and to conduct a more thorough work-up of such patients prior to recommending UFE. Recurrent or continued tumor growth following UFE should be considered a potential warning sign for sarcoma and surgery should be considered.

PRECAUTIONS :

• Do not use if the syringe or packaging appears damaged.
• Select the size and quantity of HydroPearl Microspheres appropriate for the pathology to be treated.
• Embolization with HydroPearl Microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized.

UFE SPECIFIC PRECAUTIONS:

• There is an increased chance of reflux of HydroPearl Microspheres into unintended blood vessels as uterine artery flow diminishes. Comparison of angiographic endpoint & infarction rate in individual patients indicates that best results were obtained with an endpoint close to stasis.
• The long-term outcome of UFE is at present unknown.

INSTRUCTIONS FOR USE

Preparation

• Verify that the sterile packaging was not previously compromised
• Carefully select the size of the HydroPearl Microspheres according to the size of the vessel identified and catheter used
• Directly aspirate 4 ml of contrast medium into the syringe to obtain an approximate 50%contrast and approximate 50% saline solution mix. Remove all air from the syringe.
• To evenly suspend the HydroPearl Microspheres /contrast solution, gently invert the 20 ml syringe several times.
• Attach the 20 ml syringe to one port of the luer-lock 3-way stopcock; and, if desired, a delivery catheter may be attached to the remaining port on the stopcock. Wait several minutes to allow the HydroPearl Microspheres to suspend / reach a homogenous state properly. Smaller sizes will achieve a homogenous suspension state within minutes and larger sizes may take several minutes before a homogenous suspension state is achieved
• Draw the HydroPearl Microspheres/contrast solution into the injection syringe slowly and gently to minimize the potential of introducing air into the system. Purge all air from the system prior to injection.

Delivery

• Position the catheter at the desired site and carefully evaluate the vascular network associated with the lesion using high resolution imaging prior to beginning the embolization procedure to evaluate the blood supply to the lesion
• Introduce the delivery catheter into the target vessel according to standard techniques. Position the catheter tip as close as possible to the treatment site to avoid inadvertent occlusion of normal vessels
• Choose a delivery catheter based on the size of the target vessel. HydroPearl can tolerate temporary compression of 20% to 30% in order to facilitate passage through the delivery catheter
• Inject the HydroPearl Microspheres/contrast solution from the injection syringe under fluoroscopic visualization using a slow pulsatile action, while observing the contrast flow rate.
• Always inject HydroPearl Microspheres under free flow conditions
• HydroPearl Microspheres are not radio-opaque. It is recommended to monitor the embolization under fluoroscopic visualization by adding the desired amount of contrast medium to the physiologic suspension fluid
• If there is no effect on the flow rate, repeat the delivery process with additional injections of HydroPearl Microspheres/contrast solution or larger size HydroPearl may be considered. If the HydroPearl Microspheres/contrast solution requires re-suspension, gently invert the 20 ml syringe several times.
• Avoid reflux of HydroPearl Microspheres as this can induce immediate ischemia of the tissue or the vessel. Exercise conservative judgment in determining the embolization endpoint.
• When embolizing arteriovenous malformations, choose a particle size that will occlude the nidus without passing through the AVM
• Once the endpoint is reached wait 2-3 minutes to observe whether the beads redistribute themselves and re-establish flow to the target. If flow is re-established re-inject the microspheres till the desired end point is achieved

Post Procedure

• Once the desired clinical endpoint is achieved, remove the catheter while maintaining gentle aspiration suction so as not to dislodge HydroPearl Microspheres still within the catheter lumen.
• Discard any open, unused HydroPearl Microspheres.
• Do not reprocess open, unused HydroPearl Microsphere syringes. Reprocessing may compromise sterility, biocompatibility and functional integrity of the device.

ADDITIONAL UFE SPECIFIC INSTRUCTIONS FOR USE

• Use of 800 ± 75 µm HydroPearl Microspheres is recommended to treat UFE, with upsizing to 1100 ± 75 µm if required. An endpoint of stasis or near stasis is recommended with the main uterine artery remaining patent, but with negligible residual flow toward the uterus.
• This endpoint corresponds to an angiographic image of a patent horizontal segment with absent flow in the ascending segment of the uterine artery.
• At the discretion of the physician, pneumatic compression devices may be used for patients currently taking hormone therapy, uterine volume > 1000 cc, and patients that are overweight to lower the risk of deep vein thrombosis.

UFE PATIENT COUNSELLING INFORMATION:

• Patients should have a clear understanding prior to embolization of who will provide their post procedure care and whom to contact in case of an emergency after embolization.
• UFE candidates should have an understanding of the potential benefits, risks, and adverse events associated with UFE. In particular, patients should understand that there is a chance their fibroid-related symptoms will not improve following UFE.

INTERACTION WITH PHARMACEUTICALS:
There are no known interactions between HydroPearl Microspheres and pharmaceuticals

CONSERVATION AND STORAGE:

• HydroPearl Microspheres must be stored in a place that is cool, dry and away from sunlight in the original packaging.
• Use by the date indicated on the syringe label.
• Do not freeze.

DISPOSAL:
Dispose of device/syringe in accordance with hospital policy and local regulations for biohazardous waste.

SUMMARY OF SAFETY AND CLINICAL PERFORMANCE:

• The Summary of Safety and Clinical Performance (SSCP) for the device will be accessible in the European Database on Medical Devices (EUDAMED) after the launch of the EUDAMED database ( https://ec.europa.eu/tools/eudamed ). The SSCP will be linked to the Basic UDI-DI (37015174HYDROPEARL7K) in the EUDAMED. A patient implant card is included in the package. This card should be completed and provided to the patient.
• Additional product information is available at the MicroVention website (www.microvention.com).

SYMBOLS

WARRANTY

• MicroVention warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for particular purpose. Handling, storage, cleaning and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure and other matters beyond MicroVention’s control directly affect the device and the results obtained from its use. MicroVention’s sole obligation under this warranty is limited to the repair or replacement of this device through its expiration date, and MicroVention shall not be liable for any incidental, indirect, special or consequential loss, damage or expense directly or indirectly arising from the use of this device. MicroVention neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. MicroVention assumes no liability with respect to devices reused, reprocessed or re-sterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device.
• Prices, specifications and model availability are subject to change without notice.
• © Copyright 2023 MicroVention, Inc. All rights reserved.
• MicroVention™ is a trademark of MicroVention, Inc., registered in the United States and other jurisdictions.
• © Copyright 2023 Terumo Corporation. All rights reserved.
• All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.

Manufacturer:
MicroVention Europe SARL 30 bis, rue du Vieil Abreuvoir 78100 Saint-Germain- en-Laye France
Tel: +33 (0)1 39 21 77 46
Fax: +33 (0)1 39 21 16 01
www.microvention.com

Distributed by:
MicroVention Europe 3001 Leuven
Belgium
Tel: +32 16 38 12 11
www.terumo-europe.com

IFU100137 Rev A Revised 2023-04

Documents / Resources

| MicroVention IFU100137 Hydro Pearl Micros Pheres [pdf] Instructions
IFU100137 Hydro Pearl Micros Pheres, IFU100137, Hydro Pearl Micros Pheres, Pearl Micros Pheres, Micros Pheres, Pheres
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References

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