BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8931456 · Received August 26, 2019

    Report

    Report Number
    2916596-2019-03922
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 14, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE OF (B)(6) 2019 IS AN ESTIMATION AS THE ACTUAL EVENT DATE IS UNKNOWN. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 (SHORT TERM, CAP, OR LONG TERM) CLINICAL TRIAL, IDE# G140113. FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS 00813024013297.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 (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT DEVELOPED HEART FAILURE DUE TO SEVERE MITRAL REGURGITATION AND MODERATE AORTIC INSUFFICIENCY REQUIRING SURGICAL INTERVENTION. PATIENT WAS ALSO STARTED ON INOTROPES. ADDITIONAL INFORMATION WAS REQUEST, HOWEVER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724578 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6082657 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R