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

Model Number	107801
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient was seen in the clinic for a routine follow up visit and driveline fault alarms were seen on the heartmate touch.However, no driveline fault alarms were found on the system controller.The driveline was noted to have multiple tears with multiple areas of rescue tape, but the sheath looked intact.The log file captured several driveline fault alarms throughout the event history.
Event or Problem Description
The system controller was exchanged and the alarm appeared to have cleared following the controller exchange.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: review of the submitted log file confirmed driveline fault alarms.Although a specific cause for these alarms could not be conclusively determined, based on previous complaint history, the alarms captured in the submitted log file appeared to be consistent with potential driveline wire compromise.Additionally, the reported superficial driveline damage could not be confirmed.A specific cause for the damage could not be conclusively determined through this evaluation.The submitted log file contained events from (b)(6) 2025.Persistent, silenced, driveline fault alarms, associated with yellow wrench advisories, were captured throughout the file.Electrical continuity data suggested a potential wire conductor breakdown issue with the black wire within phase 2.No other notable events or alarms were observed.Despite this finding, the pump appeared to function as intended and operated at or above the lsl for the duration of the file.Multiple attempts were made to obtain additional information regarding the event; however, no further information was provided by the account.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), and no further related events have been reported at this time.The relevant sections of the device history records for (b)(6) and driveline serial number (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 6 of the ifu, entitled "patient care and management", addresses how to care for the driveline.This section notes that the driveline should be inspected daily for signs of damage, such as cuts, holes, or tears, and should never be severely bent or kinked.Section 7, entitled "alarms and troubleshooting", outlines all system controller alarms and the appropriate actions associated with them.The heartmate ii patient handbook is also available.This handbook contains a section on "caring for the driveline." however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.Section 4, "living with the heartmate ii", contains a section titled "caring for the driveline", which discusses how to prevent damage to the driveline.The user is instructed to check the driveline daily for signs of damage (cuts, holes, tears).The user is instructed to call their hospital contact right away if the driveline is damaged (or might be damaged).The ¿alarms and troubleshooting¿ section outlines all system controller alarms, as well as how to respond to such events.The current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22509911
• Report Number: 2916596-2025-04343
• Device Sequence Number: 12958930
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(10)6915877(17)211010(11)190322
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/29/2025

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: 10/10/2021
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 6915877
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2019
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 116 KG