MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number	107801
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient was seen in the clinic with a driveline tear near where it connects to the system controller.Rescue tape was placed over it to temporarily reinforce.A clamshell repair was completed.There were no alarms associated with the driveline tear.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported tear in the driveline was confirmed through review of the submitted photo; however, a specific cause for the tear could not be conclusively determined through this evaluation.The submitted photo showed a tear in the controller connector bend relief of the driveline.The portion of the driveline visible in the photo appeared otherwise unremarkable.The patient remains ongoing on heartmate ii left ventricular assist system, serial number (b)(6), with no further related events reported at this time.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revisions of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate ii left ventricular assist system (lvas) ifu, rev.B and the heartmate ii patient handbook rev.C, are currently available.Section 6 of the ifu, ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.This section also instructs to check the driveline daily for signs of damage, such as cuts, holes, or tears.Section 8 of the ifu, ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.Section 4 of the patient handbook, ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 6 of the patient handbook, "caring for the equipment" discusses damage due to wear and fatigue of the driveline and outlines indications of driveline damage, as well as how to respond to such events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT
• 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: 24259881
• Report Number: 2916596-2026-00473
• Device Sequence Number: 13155461
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(17)190531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 107801
• Device Catalogue Number: 107801
• 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
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2016
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG