HeartMate 3 LVAS Implant Kit
Received Jul 31, 2026 · Event occurred Jul 23, 2026
Report 2916596-2026-2918845 · MDR key 50099230
Device
Generic name
Ventricular (assist) Bypass
Manufacturer
Thoratec CorporationModel number
106524INTCatalog number
106524INT
Lot number
8019510
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
It was reported that the patient passed away. The cause was not provided. Due to patient privacy laws the managing hospital would not communicate patient outcome information. Based on a review of available patient¿s record and a request for patient outcome, there were no device issues at the time of the patient outcome. It was reported that the outcome was not device or therapy related. The device was not explanted.
Additional Manufacturer Narrative
Manufacturer's Investigation Conclusion: A direct correlation between HeartMate 3 Left Ventricular Assist System (LVAS), serial number (b)(6), and the patient's outcome could not be conclusively established through this evaluation. The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications. The current revision of the Instructions for Use (IFU) can be found on the eIFU page of the Abbott website.The HeartMate 3 Left Ventricle Assist System (LVAS) Instructions for Use (IFU), Rev A is currently available.Section 1 of the IFU, ¿Introduction,¿ lists potential adverse events, including death, that may be associated with the use of the HeartMate 3 Left Ventricular Assist System. No further information was provided. The manufacturer is closing the file on this event.