BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10541125 · Received September 16, 2020

    Report

    Report Number
    2916596-2020-04372
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    March 1, 2020
    Report Date
    September 16, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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# G140113. FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION 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}. INFECTION 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

    IT WAS REPORTED THAT THE PATIENT WITH A PSEUDOMONAS DRIVELINE INFECTION BECAME INCREASINGLY RESISTANT TO ANTIBIOTICS AND STRUGGLED TO NEPHROTOXIC SIDE EFFECTS. EVENT OCCURED IN (B)(6) 2020

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006557 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 5851353

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R