BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8723765 · Received June 21, 2019

    Report

    Report Number
    2916596-2019-02768
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 23, 2019
    Report Date
    September 11, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HM3 LVAS IFU LISTS RENAL FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE COMPLAINT HAS BEEN CLOSED. ACCORDING TO OUR RECORDS, THE PRODUCT WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT PREVIOUSLY WAS ADMITTED FOR DRIVELINE INFECTION ON (B)(6) 2018 AND (B)(6) 2019 WHICH ARE REPORTED UNDER MFR #2916596-2018-02812 AND MFR #2916596-2019-00943, RESPECTIVELY. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) 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 (B)(6) TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE- 1 YEAR, 5 MONTHS. 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) 2017. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO COMPLAINT OF NAUSEA, VOMITING, AND DIARRHEA. THE PATIENT STARTED ON MEROPENEM AND CEFOTIXIN. ZYVOX, MEROPENEM, AND CEFOTIXIN WAS STOPPED DUE TO THROMBOCYTOPENIA. THE PATIENT HAD PERSISTENT NAUSEA DUE TO CHRONIC ANTIBIOTIC USE AND HAS BEEN TAKING REGLAN AS NEEDED. THE SYMPTOMS WERE ALL SIDE EFFECTS FROM THE ANTIBIOTICS. CLOSTRIDIUM DIFFICILE WAS NEGATIVE. THE PATIENT WAS GIVEN IMODIUM FOR THE DIARRHEA AND ERYTHROMYCIN. THE PATIENT CONTINUED TO HAVE THE SYMPTOMS AND HAD TO STOP TAKING IV ANTIBIOTICS. THE PATIENT WAS ONLY GIVEN LEVAQUIN DUE TO SIDE EFFECTS FROM OTHER ANTIBIOTICS. THE PATIENT BEGAN TO IMPROVE AND WAS DISCHARGED HOME ON (B)(6) 2019 WITH LEVAQUIN. THE PATIENT PREVIOUSLY WAS ADMITTED FOR DRIVELINE INFECTION ON (B)(6) 2018 AND (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515569 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6106410

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R