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); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: review of the submitted log files confirmed the reported driveline fault alarms and pump stop events.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 through review of the submitted photos.A specific cause for the damage could not be conclusively determined through this evaluation.The submitted log files collectively contained events from 04oct2025 through 15oct2025.A silenced driveline fault alarm, associated with yellow wrench advisories, was captured on 04oct2025.Electrical continuity data suggested potential wire conductor breakdown issues within all three phases.Additionally, a pump stop event, associated with low speed and low flow hazards, was captured on 15oct2025 while the patient was connected to the power module.No other notable events or alarms were observed.Despite these findings, the pump appeared to function as intended and operated at or above the low speed limit (lsl) for the duration of the file.The account submitted six images for review: five x-ray images of the pump and internal and external portions of the driveline and one photo of the external portion of the driveline.The photo of the driveline captured the entirety of the external driveline covered in white rescue tape.Review of these images were unable to confirm damage to the driveline.Multiple attempts were made to obtain additional information regarding the reported events; however, no additional information was provided by the account.The patient remained ongoing on heartmate ii lvas, serial number (b)(6), until they reportedly received a pump exchange on 16oct2025.No product was returned for evaluation.The relevant sections of the device history records for (b)(6) and the driveline, serial number (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.Sections 6 and 8 of the ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.These sections state that despite care, all heartmate ii drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time.Additionally, these sections outline indications of driveline damage as well as the how to respond to such events.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).Section 5 of the patient handbook, ¿alarms and troubleshooting¿, and section 7 of the ifu, ¿alarms and troubleshooting¿, provides information on all system alarm conditions as well as the appropriate actions associated with each condition.The patient handbook also contains a section on handling emergencies and further instructs the user to call their hospital contact if the patient thinks that, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Section a4: patient weight was requested but not yet provided.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 submitted for a patient who presented to the clinic with low voltage alarms when patient was attached to their mobile power unit (mpu).The site also observed a driveline fault on interrogation.Patient has a history of percutaneous lead repair in 2017, and a clamshell applied in 2022.Their driveline was heavily burdened with rescue tape.The data from the log file showed speed reduction and pump stopped events on (b)(6) 2025.These issues only appeared to be occurring while the device was connected to the mpu power.This type of behavior has been linked to potential issues with the percutaneous lead, and it was recommended to keep the device connected to battery power or an ungrounded patient cable and power module until further investigation is completed to prevent further interruption in support.The patient was admitted (b)(6) 2025.They had a known narrowing of ofg and the site was intending to look at this first before making a decision about external driveline repair or need for exchange.While admitted, the patient experienced a pump stop event on (b)(6) 2025 at 5:18 that from log file analysis appeared to be a short-to-shield event.It was additionally reported that the patient underwent a pump exchange to a heartmate 3 on (b)(6) 2025.

• 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: 23493305
• Report Number: 2916596-2025-06851
• Device Sequence Number: 13023781
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(11)180531
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 05/31/2018
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2015
• 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: 51 YR
• Patient Sex: Male