BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17011537 · Received May 26, 2023

    Report

    Report Number
    2916596-2023-03194
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 30, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PAIN, FEVER, AND A WET DRIVELINE EXIT SITE WITH ERYTHEMA AND A WORSENING CABLE INFECTION. DESPITE PREVIOUS ANTIBIOTIC THERAPY THERE WAS PROGRESSION OF THE DRIVELINE INFECTION. A NEW FISTULA FORMED WITH PURULENT DISCHARGE. CULTURES WERE IDENTIFIED AS STREPTOCOCCUS MITIS 10*5 KOE. A SURGICAL DEBRIDEMENT WAS PERFORMED ON (B)(6) 2023 AND THE OUTCOME WAS BETTER AFTER THE PROCEDURE BUT HAD NOT COMPLETELY RESOLVED. INTRAVENOUS ANTIBIOTIC TREATMENT WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729456 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 7298823

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention| H