Abbott FA-Q124-HF-1 HeartMate 3 LVAS Kits Owner’s Manual
- July 30, 2024
- Abbott
Table of Contents
Abbott FA-Q124-HF-1 HeartMate 3 LVAS Kits
Product Information
Specifications
- Model Number: 105581INT, 106524INT, 103393, 106015, 106016
- Model Name: HeartMate 3TM Sealed Outflow Graft with Bend Relief, HeartMate 3TM LVAS Implant Kit, HeartMate IITM Sealed Outflow Graft with Bend Relief, HeartMate IITM LVAS Implant Kit, HeartMate IITM LVAS Implant Kit
- GTIN Number: 00813024011675, 00813024011712, 00813024010807, 00813024011224, 00813024011231
Product Usage Instructions
Recognition of EOGO
EOGO (Early Outflow Graft Obstruction) can be recognized by paying attention to low flow alarms. It is crucial to monitor these alarms as they indicate a potential outflow obstruction.
Diagnosing EOGO
If low flow alarms persist and there is suspicion of EOGO, clinicians should follow the recommended steps provided in the manual to diagnose EOGO accurately.
Impact and Risks
Persistent unresolved low flow due to EOGO can lead to serious harms if not recognized or treated promptly. Clinicians must act swiftly upon detecting any symptoms of outflow obstruction to prevent adverse outcomes.
Supplemental Guidance
Clinicians are advised to carefully review the supplemental guidance and recommendations outlined in the manual to ensure proper management of EOGO cases and to prevent associated risks.
FAQs
- Q: Do I need to return any product to Abbott if EOGO is suspected?
- A: No, there is no need to return any product to Abbott if EOGO is suspected. Follow the recommended steps for diagnosing EOGO provided in the manual.
- Q: What is the first symptom of significant outflow obstruction?
- A: The first symptom of significant outflow obstruction is low flow alarms. Clinicians should pay close attention to these alarms for early detection of potential issues.
URGENT Field Safety Notice
FA-Q124-HF-1
HEARTMATE 3TM LVAS KITS & HEARTMATE 3 OUTFLOW GRAFTS HEARTMATE IITM LVAS KITS
& HEARTMATE II OUTFLOW GRAFTS
Heart Failure Division Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 USA
February 2024
Dear Valued Customer,
Abbott is writing to notify you of a planned update to our Instructions for
Use associated with observed outflow graft deformation known as “Extrinsic
Outflow Graft Obstruction” (EOGO) associated with the HeartMate 3TM Left
Ventricular Assist System (LVAS) and HeartMate IITM LVAS. Significant EOGO
will manifest clinically as a persistent low flow alarm under certain
circumstances in some patients, and in such cases, may impair the ability of
the HeartMate LVAS to provide adequate hemodynamic support. Refer to Appendix
A for a complete list of impacted product model numbers.
This letter contains important information on how to recognize EOGO and
recommended steps to diagnose EOGO. There is no need to return any product to
Abbott.
EOGO is caused by the accumulation of biological materials (acellular
biodebris) between the HeartMate Outflow Graft and the Outflow Graft Bend
relief or a non-HeartMate component (such as a Gore-Tex/PTFE conduit or wrap
added by the surgeon during implant). The biodebris accumulation happens over
a long period of support (typically longer than 2 years) and has similar
clinical effects between HeartMate 3TM LVAS and HeartMate IITM LVAS. The
HeartMate 3TM LVAS Kaplan Meier estimate of the rate of EOGO post-implant is
0.24% at 2 years and 2.06% at 5 years.
Impact and Associated Risks
Significant clinical manifestations of EOGO may include constriction of the
outflow graft leading to persistent low flow alarms or low flow. Persistent
low flow, if not treated, may result in: hemodynamic compromise, the need for
surgical intervention, including possible pump replacement, and risk of death.
Continued use of the HeartMate LVAS is safe with the guidance described in
this letter. In summary, the intention of this letter is to provide
information for the clinicians, and there is no need to return any product to
Abbott.
Supplemental Guidance and Recommendations
It is important that clinicians continue to pay attention to low flow alarms
as this is the first symptom of significant outflow obstruction. Persistent
unresolved low flow, if unrecognized or left untreated, can lead to the
abovementioned harms.
The following information provides guidance on how to diagnose unresolved low
flow associated with outflow graft obstruction and recommended actions. A
clinical article published in 2018 (Mehra et al. J Heart Lung Transplant. 2018
Nov;37(11):1281-1284.) includes a suggested diagnostic algorithm to recognize
outflow graft obstruction for HeartMate 3 LVAD in the context of outflow graft
twist. This published approach is appropriate to determine if significant EOGO
is present and contributing to observed low flow alarms that are not able to
be resolved. In summary, the Mehra et al. algorithm identifies the following
approach for unresolved low flow alarms:
· If the patient presents with symptoms such as a trend to reduced flow with
no improvement back to baseline or persistent low flow alarms (with or without
symptoms), the first step is to rule out other clinical conditions that could
cause low flow.
· If the patient’s signs or symptoms persist, it is important to rule out
compression of the outflow graft through imaging such as a CT Angiogram.
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Upon diagnosing EOGO, the clinician has options to treat this condition, which
include: patient monitoring, percutaneous intervention like outflow graft
stenting, surgical decompression by opening the bend relief, or pump
replacement. There are inherent risks to any procedure to address EOGO,
dependent on the preoperative stability of the patient. Abbott will update the
Instructions for Use (IFU) to include additional diagnostic recommendations
related to persistent low flow and related risks associated with EOGO. In
addition, Abbott is in the process of developing and qualifying a design
solution to minimize the accumulation of biodebris on the outflow graft and
will implement it upon completion of the qualification and receiving
regulatory approvals. Initial investigation determined that histology of the
material between the graft and bend relief after implementation of the
proposed design solution differs from biodebris and is similar to the cellular
collagenous connective tissue that surrounds the graft where no wrap exists
and no EOGO has been observed. This design solution will be developed only for
HeartMate 3 outflow grafts; as previously communicated, HeartMate II LVAS will
be discontinued. Please report any adverse reactions or quality problems
experienced with the use of these products to your local Abbott
representative. Please distribute this notice to those who need to be aware of
this information within your institution and complete the attached
acknowledgement form. Abbott has notified applicable regulatory agencies about
this issue. Should you have any questions about this communication, please
contact your local Abbott representative. Abbott is committed to providing the
highest quality products and support. We sincerely apologize for any
inconvenience this issue may have caused.
Sincerely,
Elizabeth Boltz Divisional Vice President, Quality Abbott Heart Failure
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Appendix A
Model Number Model Name
105581INT 106524INT 103393 106015 106016
HeartMate 3TM Sealed Outflow Graft with Bend Relief HeartMate 3TM LVAS Implant Kit HeartMate IITM Sealed Outflow Graft with Bend Relief HeartMate IITM LVAS Implant Kit HeartMate IITM LVAS Implant Kit
GTIN Number
00813024011675 00813024011712 00813024010807 00813024011224 00813024011231
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