BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 23340215 · Received October 20, 2025

    Report

    Report Number
    2916596-2025-06657
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    January 1, 2017
    Report Date
    November 6, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED SUPERFICIAL DRIVELINE DAMAGE COULD NOT BE CONFIRMED. A SPECIFIC CAUSE FOR THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS COMMUNICATED THAT THE ONSET DATE OF THE DRIVELINE DAMAGE WAS UNSURE BUT LONGSTANDING. THE PATIENT REMAINED ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), UNTIL THEY REPORTEDLY RECEIVED A PUMP EXCHANGE (CAPTURED UNDER PER-2025-0160590, CS-218391). 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.

    Additional Manufacturer Narrative · 0

    B3- THE EVENT DATE WAS ESTIMATED. NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LONGSTANDING HISTORY OF EXTENSIVE EXTERNAL DRIVELINE DAMAGE (GREATER THAN SEVEN YEARS) AND HAD RESCUE TAPE REINFORCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452279 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female