BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7188573 · Received January 12, 2018

    Report

    Report Number
    2916596-2018-00161
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 18, 2017
    Report Date
    January 12, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE AT TIME OF EVENT, SEX, AND WEIGHT WERE REQUESTED, BUT NOT PROVIDED. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23AUGUST2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE - 0 DAY. THE PUMP REMAINS IMPLANTED; HOWEVER, THE OUTFLOW GRAFT (LOT # 191414) IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SURGEON CONFIRMED THAT THE OUTFLOW GRAFT BEND RELIEF (OFGBR) CLICKED INTO PLACE; HOWEVER, OBSERVED THAT IT WOULD NOT ROTATE OR SPIN FREELY LIKE HE WAS USED TO SEEING IN PREVIOUS IMPLANTS. THE SURGEON THEN USED THE HEARTMATE 3 SURGICAL TOOL TO DISENGAGE THE OFGBR AND TRIED IT AGAIN WITH THE SAME RESULT OF HAVING FRICTION AND NOT ROTATING. THE SURGEON WAS NOT COMFORTABLE USING THIS GRAFT AND CHOSE TO USE ANOTHER. THERE WAS NO ADVERSE IMPACT TO THE PATIENT DUE TO THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30758 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1