BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8009721 · Received October 26, 2018

    Report

    Report Number
    2916596-2018-04792
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    October 10, 2018
    Report Date
    February 24, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REPORT OF A TEAR IN THE DRIVELINE METAL CONNECTOR BEND RELIEF, REQUIRING A CLAMSHELL REPAIR WAS CONFIRMED THROUGH AN ONSITE EVALUATION PERFORMED BY AN ABBOTT REPRESENTATIVE. A CLAMSHELL REPAIR WAS SUCCESSFULLY PERFORMED ON (B)(6) 2018 UNDER WORK ORDER (B)(4). THE WORK ORDER NOTED THAT THE CONNECTOR-END BEND RELIEF WAS TORN. THE PATIENT WAS ASYMPTOMATIC AND THERE WERE NO FURTHER ISSUES FOLLOWING THE REPAIR. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE SEPARATION OF THE DRIVELINE'S SILICONE SLEEVE WAS PREVIOUSLY INVESTIGATED AND IT WAS DETERMINED THAT SUFFICIENT SIDE LOADING APPLIED ON THE SILICONE SLEEVE WHILE IT IS CONNECTED TO THE SYSTEM CONTROLLER CAN CONTRIBUTE TO THE SEPARATION OF THE SLEEVE FROM THE NIPPLE OF THE METAL CONNECTOR. IT WAS DETERMINED THAT THIS SEPARATION IS A DESIGN-RELATED ISSUE AND IT HAS BEEN ADDRESSED BY CAR #20099. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) (DOCUMENTS 165687, 163385, AND 162688) 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.

    Additional Manufacturer Narrative · 1

    AGE OF DEVICE: 4 YEARS, 7 MONTHS, 29 DAYS. THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2014. IT WAS REPORTED THAT PERCUTANEOUS LEAD CONNECTED END BEND RELIEF WAS TORN AND A CLAMSHELL REPAIR WAS SCHEDULED AND WAS PERFORMED ON (B)(6) 2018. PATIENT WAS ASYMPTOMATIC AT THE TIME OF EVENT. NO FURTHER ISSUES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850126 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other