BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10043781 · Received May 11, 2020

    Report

    Report Number
    2916596-2020-02482
    Event Type
    Injury
    Date Received
    May 11, 2020
    Date of Event
    January 19, 2018
    Report Date
    May 11, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# G140113. FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23AUG2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE 3 LVAS IS (B)(4). MANUFACTURER'S INVESTIGATION CONCLUSION: 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 RETURNED TO THE OPERATING ROOM (OR) ON (B)(6) 2018 DUE TO A STERNAL WOUND DEHISCENCE (PATIENT WAS IMPLANTED ON (B)(6) 2018). THE PATIENT HAD A STERNAL WIRE REMOVED DURING ADMISSION. THE SITE REPORTED A DEBRIDEMENT WAS PERFORMED AND A WOUND VAC WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508100 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6036878

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R