BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8169561 · Received December 17, 2018

    Report

    Report Number
    2916596-2018-05429
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 17, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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- 1 YEAR, 5 MONTHS. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS URGENTLY SEEN IN CLINIC DUE TO COMPLAINT OF WEAKNESS. THE PATIENT HAD INR OF 1.7 AND HFB OF 7.8 G/DL. THE PATIENT WAS TAKING COUMADIN DAILY. THE PATIENT RECEIVED 2 UNITS OF PLASMA RED BLOOD CELL (PRBC). AT THE TIME OF EVENT, THE PATIENT WAS TAKING WARFARIN. ON (B)(6) 2018, ENTEROSCOPY WAS PERFORMED ON PATIENT AND WAS UNREMARKABLE. THE PATIENT HAD A STABLE INR OF 1.5 AND HEMOGLOBIN LEVEL AT 8.4 G/DL. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 AND WILL HAVE SMALL BOWEL CAPSULE TEST AS OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010920 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 5704904

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R