BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7701185 · Received July 18, 2018

    Report

    Report Number
    2916596-2018-02839
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    September 20, 2017
    Report Date
    July 18, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SUBMISSION OF THIS EVENT WAS REPORTED BY THE MANUFACTURER UNDER MFR. REPORT # 2916596-2017-02388. THIS REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. 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- 48 DAYS. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PATIENT REMAINED ONGOING ON VAD SUPPORT UNTIL THEY EXPIRED ON (B)(6)2017. THE PUMP WAS RETURNED AND EVALUATED UNDER (B)(4). A CORRELATION BETWEEN THE REPORTED DROP IN HEMOGLOBIN AND THE EVALUATION OF (B)(4) CANNOT BE CONCLUSIVELY DETERMINED. DEVICE HISTORY RECORDS (SHOP ORDER: 176556, 177657, 187416, 189780, 190368, 192236, 193318) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS (B)(4) WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2017 IN CUSTOMER ORDER . NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THE PATIENT PRESENTED WITH A DROP IN HEMOGLOBIN (HGB) TO 6.1 G/DL. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS AND THEIR HGB WENT TO 10.5 G/DL. THERE IS A CONCERN FOR GASTROINTESTINAL BLEEDING (GI) AND A CT OF THE ABDOMEN AND PELVIS WAS ORDERED; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE PATIENT WAS REMOVED FROM TUBE FEEDING AND THEIR HEMOGLOBIN AND HEMATOCRIT WILL BE MONITORED. ANTICOAGULANTS AT THE TIME OF EVENT WERE HEPARIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543280 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6073382

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR