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

Model Number	104911
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer submitted images of the driveline outer layer damage covered by rescue tape.The driveline seemed extremely fragile, paper thin like, and with multiple areas of small tears that required rescue tape.The images submitted showed areas that appeared to have existing areas covered by rescue tape.Log files were sent for review.The log file data showed no indications of conductor wear or damage.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: review of the submitted images confirmed the reported driveline damage.A specific cause for the damage could not be conclusively determined through this evaluation.The account submitted four images of the external driveline for review.The first three images captured twisting of the outer jacket material, as well as a portion of the driveline covered in black tape.The fourth images captured the entire external portion of the driveline with a mid-section covered in black tape, as well as black tape covering an area of the driveline above the bend relief.The submitted log file contained events from (b)(6) 2025 through (b)(6) 2025.No notable events or alarms were captured, and the pump appeared to function as intended for the duration of the file.Multiple attempts were made to obtain additional information regarding the reported events; however, no additional information was provided by the account.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6), with no further related events reported.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas ifu and the heartmate ii patient handbook are currently available.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.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 (WITH SEALED GRAFTS)
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23163976
• Report Number: 2916596-2025-06324
• Device Sequence Number: 18549316
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)151031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 10/21/2025

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: 10/31/2015
• Device Model Number: 104911
• Device Catalogue Number: 104911
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/28/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2014
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 79 KG