BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 15236716 · Received August 16, 2022

    Report

    Report Number
    2916596-2022-12939
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    April 3, 2019
    Report Date
    August 24, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY MW NUMBER 3400-300000-2021-0000028 WAS RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MAIN INVESTIGATION CONCLUSION: THE REPORT OF A TEAR IN THE DRIVELINE COULD NOT BE CONFIRMED AS THE DRIVELINE IS NOT AVAILABLE FOR INVESTIGATION AND NO PHOTOS OF THE REPORTED DAMAGE WERE SUBMITTED. ADDITIONALLY, A SPECIFIC CAUSE FOR THE REPORTED TEAR COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE PATIENT REMAINS ONGOING ON (B)(6). 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. THIS SECTION ALSO INSTRUCTS TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. 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 6 "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. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PATIENT WAS AT THE CLINIC A TEAR IN THEIR DRIVELINE WAS FOUND AND REPAIRED WITH RESCUE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238952 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male