Lifetech SCIENTIFIC HeartR Atrial Septal Defect ASD Occluder Instruction Manual

Lifetech SCIENTIFIC HeartR Atrial Septal Defect ASD Occluder

SYMBOLS

The Summary of Safety and Clinical Performance (SSCP) of this device is available in the European database on medical devices (Eudamed) by searching the Basic UDI-DI “69383701000300U5” at:  https://ec.europa.eu/tools/eudamed.

Device Description

• The HeartRTM Atrial Septal Defect (ASD) Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. The system includes the HeartRTM ASD Occluder and the SteerEaseTM Introducer. The HeartRTM ASD Occluders have two types, HeartRTM ASD Occluder and HeartRTM Multi-fenestrated (Cribriform) ASD Occluder as shown in Figure 1. The HeartRTM ASD Occluder is a self-expandable double disc device, which is made of a nitinol wire mesh that is shaped into two flat discs and a waist between the two discs to fit the defect size.
• PET membranes sewn into each disc and the waist (no PET membrane sewn into the waist for multi fenestrated ASD occluder) help to seal the hole and provide a foundation for the growth of tissue over the occluder after placement.
• HeartR ASD Occluder contains NiTi (80%-95%), stainless (2%-20%), PA (0.1%-0.8%), and PET (1.2%-8.9%).

• The HeartRTM ASD Occluder must be used in combination with the SteerEaseTM Introducer. The introducer contains a coil-reinforced sheath, a dilator, a loader, a haemostatic valve and a delivery cable. The introducer is used to advance the HeartRTM ASD Occluder to the proper position. When the occluder is released from the sheath, one disc expands on each side of the defect. At the same time, the waist expands to its pre-determined diameter and closes the hole between the left and right atria.
• Sheath: The sheath is used to advance the device to its desired position.
• Hemostatic valve: The haemostatic valve at the proximal end of the sheath minimizes bleeding. The sideport with the flexible extension tube and stopcock are used to flush the system.
• Dilator: The dilator is used to ease penetration of tissues and the vessel wall
• Loader: The loader is used to introduce the occluder with the attached delivery cable into the sheath.
• Delivery cable: The delivery cable is used to advance the occluder through the sheath, and hold it in position while the sheath is pulled back to deploy the occluder and to retrieve it, if either the size, the position or the expansion of the occluder are deemed to be unsatisfactory.
• Plastic vice: The plastic vice screwed to the proximal end of the delivery cable is used to facilitate direction control and serve as a “handle” for disconnecting (unscrewing) the delivery cable from the device.

Clinical benefit
Clinical benefit is determined by the indication of the use of the device as well as clinical background information on the condition treated. Atrial Septal Defect (ASD) is one of the most common congenital heart defects to present in adulthood. Untreated, ASD produces right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, and pulmonary hypertension. Transcatheter closure of ASD has been widely accepted by doctors and patients because of the minimum of trauma, and effectiveness.
Benefits of the ASD Occluders involve

• Positive impact on subjects’ clinical condition including improvement of fatigue, shortness of breath, swelling of legs, feet, and abdomen
• Lowering the risk of stroke
• Preventing/resolving; right heart volume overload and progressive impairment, including;
  • reduced aerobic capacity
  • atrial dysrhythmias
  • congestive heart failure
  • pulmonary hypertension
• Minimally invasiveness because of the percutaneous, transcatheter method. Limiting hospitalization time, blood loss and scarring.

Indications and Usages

• The HeartRTM ASD Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defect (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.
• Patients indicated for ASD closure have echocardiographic evidence of ostium secundem atrial septal defect and clinical evidence of right ventricular volume overload.

Contraindications

• Patients are known to have extensive congenital cardiac anomalies which can only be adequately repaired by way of cardiac surgery.
• Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months.
• Patients are known to have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
• Any patients for whom the radius of the device is greater than the distance from the central defect to the aortic root or superior vena cava (for the Multi-Fenestrated (Cribriform) ASD Occluder).

Warnings

• Patients allergic to nickel may suffer an allergic reaction to the device.
• The HeartRTM ASD Occluder and the SteerEaseTM Introducer should only be used by physicians trained in transcatheter defect closure techniques.
• Physicians must be prepared to deal with emergency situations that require the removal of embolized devices that result in critical hemodynamic compromise. This includes the availability of an onsite surgeon.
• Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
• The HeartRTM ASD Occluder and SteerEaseTM Introducer are for single use only. Do not reuse or resterilize. Structural integrity and/or function may be impaired or be lost through cleaning, resterilization, or reuse and may cause adverse patient reactions. Lifetech will not be responsible for any direct or consequential damages or expenses resulting from the reuse of any of the components in the HeartRTM ASD Occluder and SteerEaseTM Introducer.
• Do not use if the sterile barrier has been compromised in any way.
• Do not release the HeartRTM ASD Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy it. If still unsatisfactory, recapture the device and replace with a new device.
• Implantation of this device may not eliminate the need for Coumadin in patients with ASD and paradoxical embolism
• The use of echocardiographic imaging (TTE, TEE or ICE) is required. Do not inflate the sizing balloon beyond the cessation of the shunt (i.e., stop-flow) or the visualization of a small waist in the balloon. Do not overinflate.
• Do not select a device size greater than 1.5 times the ASD diameter measured by the echocardiographic – device prior to balloon sizing.

Precautions

• The use of the device has not been studied in patients with patent foramen ovale.

• The HeartRTM ASD Occluder and the SteerEaseTM Introducer are for single use only. Do not reuse or resterilize.

• Patient Selection
  Certain patients may be at higher risk for complications such as tissue erosion and device embolization. If higher-risk patients have devices implanted, closer follow-up is warranted. Higher-risk patients include the following:

• Patients with deformation of the device at the aortic root.

• Patients with high defects (minimal aortic and superior rims).

• Patients with IVC rim deficiency (risk of device embolization).

• Pre-procedure, procedure and post-procedure

• Pre-procedure

• Aspirin (3-5 mg/kg/day) is to be started at least 24 hours prior to the procedure. In the rare case of aspirin intolerance, two times 200 mg of Ticlopidin are given. Cephalosporin therapy is optional.

• Procedure
  The patient should be fully heparinized throughout the procedure with a minimum active clotting time (ACT) of 250 seconds prior to device insertion.
  Transesophageal echocardiography (TEE) or similar imaging equipment is recommended as an aid in placing the HeartRTM ASD Occluder. If TEE is used, the patient’s esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

• Post-procedure

• Endocarditis prophylaxis should be followed according to the Medical Guideline recommendations.

• Patients, who had any residual shunt, should be inspected by echocardiographic examination for the residual shunt until the defect closed completely.

• MR Conditional
  A patient with an implanted HeartRTM ASD Occluder can be scanned safely immediately after placement of the device under the following conditions:

• Static magnetic field of 3 T or less.

• Spatial gradient magnetic field of 680 G/cm or less.

• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.

• In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the ASD occluder when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system.

Potential Adverse Events

• Placement of the HeartRTM ASD Occluder involves using standard interventional cardiac catheterization techniques.
  • The following adverse events might occur from interventional cardiac catheterization techniques or from devices.
  • Allergic reaction
  • Arrhythmias
  • Arterial fistula or left or right atrial fistula
  • Thrombus formation
  • Septal tearing
  • Device migration
  • Injury to the nerve or vessel well: Cardiac perforation
  • Incomplete sealing of the defect: Infection
  • Mitral insufficiency: Cardiac tamponade
  • Fever
• Notice: any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Product Features

• The HeartRTM ASD Occluder and the SteerEaseTM Introducer are packaged separately.
• The occluder and introducer are available in the following (Figure 3 & Table 1).

Table 1 List of specifications of the HeartRTM ASD Occluder and recommended introducers

Occluders

specification

| ΦD| ΦD1| ΦD2| L| Recommended sheath

size

---|---|---|---|---|---
HeartRTM ASD Occluder
XJFS06| 6| 14| 18| 4| SFA7F-8F
XJFS08| 8| 16| 20| 4| SFA7F-8F
XJFS10| 10| 18| 22| 4| SFA7F-8F
XJFS12| 12| 22| 26| 4| SFA8F-9F
XJFS14| 14| 24| 28| 4| SFA9F-10F
XJFS16| 16| 26| 30| 4| SFA9F-10F
XJFS18| 18| 28| 32| 4| SFA9F-10F
Occluders specification| ΦD| ΦD1| ΦD2| L| Recommended sheath size
---|---|---|---|---|---
XJFS20| 20| 30| 34| 4| SFA10F-12F
XJFS22| 22| 32| 36| 4| SFA10F-12F
XJFS24| 24| 34| 38| 4| SFA12F
XJFS26| 26| 36| 40| 4| SFA12F
XJFS28| 28| 38| 42| 4| SFA12F
XJFS30| 30| 40| 44| 4| SFA12F-14F
XJFS32| 32| 42| 46| 4| SFA12F-14F
XJFS34| 34| 44| 50| 4| SFA14F
XJFS36| 36| 46| 52| 4| SFA14F
XJFS38| 38| 48| 54| 4| SFA14F
XJFS40| 40| 50| 56| 4| SFA14F
XJFS42| 42| 52| 58| 4| SFA14F
HeartRTM Multi-Fenestrated ASD Occluder
XJFS1818| —| 18| 18| 3| SFA8F-9F
XJFS2518| —| 25| 18| 3| SFA9F-10F
XJFS2525| —| 25| 25| 3| SFA9F-10F
XJFS3030| —| 30| 30| 3| SFA10F-12F
XJFS3525| —| 35| 25| 3| SFA12F-14F
XJFS3535| —| 35| 35| 3| SFA12F-14F
XJFS4040| —| 40| 40| 3| SFA12F-14F

Individualization of Treatment

• Patients Selection
• Device placement should only be attempted in those patients with a sufficient rim around the defect to allow stable seating of the device.
• Patients with multiple ASDs
• Closure of multiple ASDs by common ASD occluder(Figure 1 a) should only be attempted by those physicians who have gained sufficient experience (greater than 10-15 cases) to undertake more technically challenging procedures.
• If there are two large ASDs separated by more than a 7 mm rim of tissue, then the implantation of two devices may be justified.
• If there are multiple ASDs close to each other, one device may be used to cover all defects when placed in the largest defect.
• Device placement and size selection
• Device placement should only be done with the assistance of TEE or similar imaging equipment.
• Select an occluder about 2-4 mm in diameter larger than the ASD defect (refer to Table 1).
• Use in specific populations
• Pregnancy — Care should be taken to minimize the radiation exposure to the fetus and the mother.
• Nursing Mothers — Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachable in breast milk.

Directions for Use

• Perform general or local anesthesia. If TEE is used, the patient has to be intubated endotracheally.
• Following percutaneous puncture of the femoral vein, perform a standard right heart catheterization.
• Perform an angiogram in order to demonstrate the atrial communication. Catheterize the left atrium using a 45° LAO position and a 35-45°, cranial angulation, and inject a contrast medium into the left atrium or into the right superior pulmonary vein.
• Introduce a “J” tip exchange guidewire into the left atrium or left superior pulmonary vein. Insert a compliant sizing balloon catheter over the exchange wire into the left atrium and measure the defect size.
• Remove the balloon catheter leaving the exchange guidewire in place.
• Flush the dilator, and sheath with saline solution, and then insert the dilator into the sheath.
• Advance the sheath with a dilator over the exchange guidewire through the septum defect into the left superior pulmonary vein. Remove the exchange guidewire and dilator (Refer to Figure 4).
• Pass the delivery cable through the loader and screw the device to the tip of the delivery cable. Once securely attached, immerse the device and loader in saline solution and pull the device into the loader with a jerking motion. Flush the device via the side arm (Refer to Figure 5).

• Attach the loader to the sheath. Advance the occluder into the sheath by pushing (not rotating) the delivery cable.

• Under fluoroscopic and echocardiographic guidance, deploy the LA disc and waist and pull the device gently against the atrial septum, which can be felt and also observed by ultrasound imaging. Then immobilize the delivery cable, pull the sheath back and deploy the right atrial disk. Pull the sheath back by approximately 5-10 cm. A gentle
  “forward and backward” motion with the delivery cable verifies a secure position across the atrial septal defect, which can also be observed by TTE or TEE (Refer to Figure 6).

• Confirm correct placement. If device placement is unsatisfactory or if the device does not reconfigure to its original shape, retract the device into the sheath and redeploy or replace it with a new device.

• Release the device. Release the device by rotating the vise counterclockwise.

Post-procedure

• All patients should be kept overnight for observation.
• Anticoagulation treatment with heparin for 24 hours.
• Oral anticoagulation with Aspirin 3-5 mg/(kg.d) for children, and 3 mg/(kg.d) for adults, 6 months; conditionally, plus Plavix 75 mg/d for some adult patients.
• Antibiotic therapy.
• Re-examination by echocardiography, ECG and chest X-ray at 24 hours, 1, 3, 6 and 12 months respectively, after the procedure.
• Higher-risk patients should be followed more closely, including the following:
• Clinical follow-up with echocardiogram one week following device implantation.
• Education of patients about the higher risk and the need for echocardiography in case of symptoms (i.e., chest pain or shortness of breath).

Expiry Date

• Both the HeartRTM ASD Occluder and the SteerEaseTM Introducer are sterilized by ethylene oxide. The production date and expiry date are marked on the label. DO NOT use the overdue product.

Package and Label

• The HeartRTM ASD Occluder is supplied sterile. The HeartRTM ASD Occluder and the SteerEaseTM Introducer are packaged separately.
• The HeartRTM ASD Occluder is packaged and protected in a PETG box sealed with Tyvek paper, and then the product is sealed with another Tyvek pouch, on which a label and a sterilization indicator are attached. The product is sterilized and put in a box with IFU, patient care, customer feedback form and quality guarantee card. An outer label is attached on the box.
• All the components of the SteerEaseTM Introducer are fixed and protected on scale boards, then sealed in two Tyvek pouches, where a label and a sterilization indicator are attached. The product is sterilized and put in a box with IFU, customer feedback form and certificate of compliance.
• The primary label is attached to the box.

Manufacturer

• Lifetech Scientific (Shenzhen) Co., Ltd
• 8F, LifeTech Scientific Building,
• No.22, Keji 12th Road South, High-tech Industrial Park,
• Yuehai Subdistrict, Nanshan District, Shenzhen 518063,
• P. R. China.
• Tel: +86 755 86026250
• Fax: +86 755 86026251
• Email: lifetechmed@lifetechmed.com.

EU authorized representative

• LifeTech Scientific (Europe) Coöperatief U.A
• Oliemolenstraat 60, 6416CB Heerlen, the Netherlands

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