HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
Recall
- Recall Number
- Z-1300-2024
- Event Number
- 93963
- Firm
- Thoratec Corp.
- FEI Number
- 2916596
- Product Code
- DSQ
- Status
- Open, Classified
- Root Cause
- Material/Component Contamination
- Initiated
- February 19, 2024
- Posted
- March 22, 2024
- Address
- 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270
Description
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
On 02/19/2024, the firm will hand deliver an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers that informs them of Abbott's planned update to Instructions for Use associated with observations of outflow graft deformation known as "Extrinsic Outflow Graft Obstruction" (EOGO) associated with the HeartMate 3 and HeartMate II Left Ventricular Assist Systems (LVAS) which may manifest clinically as a persistent low flow alarm under certain circumstances in some patients and may impair the ability of the LVAS to provide adequate hemodynamic support. Guidance and Recommendations: Continue to pay attention to low flow alarms, the first symptom of significant outflow obstruction. -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." 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 signs or symptoms persist, it is important to rule out compression of the outflow graft through imaging such as a CT Angiogram. Abbott will update the Instructions for Use to include additional diagnostic recommendations and is in the process of developing and qualifying a design solution. for questions, contact Abbott Technical Support at 1-800-456-1477.
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