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

Model Number	107801
Medical Device Problem Codes	Mechanical Problem (1384); Decreased Pump Speed (1500)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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 complete.
Event or Problem Description
It was reported that log files were sent for review.The log captured multiple low speed advisories on (b)(6) 2025 and (b)(6) 2025 while the patient was connected to wall power.There were no other unusual events recorded in the log file event history.The mechanical circulatory support (mcs) equipment had operated as intended.Tech services were on site on (b)(6) 2025 and performed a short to shield driveline repair.The splice was approximately 3 inches from the exit site.The excised driveline was shipped for an urgent analysis.The patient used an ungrounded patient cable and would remain in the hospital and on the cable until analysis was completed.Additional log files were sent for review.The log file captured the events from the driveline repair on (b)(6) 2025 at 17:21.Since that time there had been no further low speed or pump off events.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the submitted log file confirmed low speed events; however, a direct cause for these findings could not be conclusively determined through this evaluation.A review of the submitted log files revealed low speed events while the patient was connected to the power module and mobile power unit (mpu).Based on previous complaint experience, these events could be indicative of a potential issue with the driveline.A distal end driveline replacement was performed by a tech services representative on 07aug2025.Approximately 21.5¿ of the external portion/distal end of the driveline was returned.An electrical continuity test of the returned driveline, in the condition it was received, was conducted, and all wires were found to be electrically intact.No wire-to-wire or wire-to-shield shorts were induced during this testing, even with manipulation of the driveline.The outer jacket of the driveline was removed, and the bionate layer revealed a dark discoloration throughout its length but was otherwise unremarkable.Areas of the metal braided shield breakdown were observed that appeared consistent with the duration of use.The shielding and bionate were removed, and examination of the underlying wires revealed no insulation breaches or damage.The returned portion of the driveline was then submerged in a saline bath for high potential testing to verify the integrity of each wire¿s insulation.The test did not reveal any areas of current leakage.Multiple attempts for additional information were sent to the customer; however, no further information has been provided at this time.The patient remained ongoing on heartmate ii left ventricular assist system, serial number (b)(6), until they underwent a transplant on 21aug2025 (manufacturer report #2916596-2025-05680).The relevant sections of the device history records for vad-21192 and driveline, serial number (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications the current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 6 ¿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.Section 7 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The heartmate ii lvas patient handbook is also currently available.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.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: 22890608
• Report Number: 2916596-2025-05384
• Device Sequence Number: 8852137
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(17)240820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 08/20/2024
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 8214419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White