MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP; Ventricular (assist) bypass

Model Number	103695
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/15/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number: (b)(6), and the patient outcome could not be conclusively determined through this evaluation.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii lvas ifu, 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.The relevant sections of the device history record for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient passed away.The patient transitioned to comfort measures only with a bowel obstruction and was not a surgical candidate.The ventricular assist device (vad) coordinators stated that the outcome was not device or therapy related.The device was not explanted.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP
• Common Device Name: Ventricular (assist) bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24164338
• Report Number: 2916596-2026-00469
• Device Sequence Number: 9028915
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616(17)130930
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2013
• Device Model Number: 103695
• Device Catalogue Number: 103695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 84 KG