BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19779747 · Received July 18, 2024

    Report

    Report Number
    2916596-2024-04489
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    April 2, 2024
    Report Date
    July 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE ¿ 02APR2024 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. B5: MILLER, ALANNA; ET AL. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, SUPPL. SUPPLEMENT83.13: 2969. ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/S0735-1097(24)04959-3 PENN PRESBYTERIAN MEDICAL CENTER, PHILADELPHIA, PA, UNITED STATES. D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: 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 · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿THE EFFECTS OF RECURRENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) DRIVELINE INFECTION ON HEART FAILURE DIAGNOSTIC TRENDS IN AN IMPLANTED CARDIAC DEVICE?¿ IDENTIFYING THAT HEARTMATE 3 (HM3) IS ASSOCIATED WITH DRIVELINE INFECTION AND EXACERBATION OF HEART FAILURE (HF). THIS IS A CASE STUDY OF A 73 Y/O MAN WITH HM3 IMPLANTED IN 2019, WAS NOTED TO HAVE ELEVATED HF INDICES DURING A HF MONITORING PROTOCOL. HE WAS CONTACTED AND HAD NO CLINICAL SYMPTOMS OF HF; THOUGH, HE DID NOTE REDNESS AND DRAINAGE AROUND HIS LVAD DRIVELINE. AFTER EVALUATION, CULTURES WERE NOTED TO BE POSITIVE FOR PSEUDOMONAS. HE WAS STARTED ON ORAL ANTIBIOTICS AND HAD DRIVELINE SITE DEBRIDEMENT WITH DRIVELINE REPOSITIONING. HF INDICES DECREASED TO NORMAL LEVELS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033226 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention