BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15853083 · Received November 23, 2022

    Report

    Report Number
    2916596-2022-15036
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    June 14, 2022
    Report Date
    December 6, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4846 - BACTEREMIA. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT¿S BACTEREMIA COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2022 AFTER BEING PLACED ON HOSPICE (RELATED MANUFACTURER REPORT NUMBER 2916596-2022-152126). (B)(6) WOULD REPORTEDLY NOT BE RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS LOCALIZED INFECTION, STROKE, AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION ALSO INCLUDES INFORMATION REGARDING HOW TO PREVENT AND CONTROL INFECTION. SECTION 6 PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) RANGE. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, CONTAINS SEVERAL SECTIONS WITH INFORMATION ABOUT HOW TO PREVENT AND CONTROL INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) BACTEREMIA IDENTIFIED THROUGH A POSITIVE BLOOD CULTURE AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022. THE PATIENT ALSO EXPERIENCED A SUBARACHNOID AND SUBDURAL HEMATOMA ON (B)(6) 2022. THE HEMATOMA WAS DIAGNOSED VIA COMPUTED TOMOGRAPHY (CT) IMAGING AND NO INTERVENTION WAS PERFORMED. THE INFECTION WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354933 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7760398 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R