BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11302691 · Received February 9, 2021

    Report

    Report Number
    2916596-2021-00266
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 9, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4). THE HEARTMATE 3 LVAS IFU, REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-023639 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 20NOV2020. 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 WAS ADMITTED TO THE HOSPITAL WITH A HEMOGLOBIN RESULT OF 6.9 G/DL AFTER A ROUTINE OUTPATIENT LAB DRAW. ALL DIAGNOSTIC TESTING AND ESOPHAGOGASTRODUODENOSCOPY (EGD) WERE NEGATIVE. THE CAUSE OF BLEEDING WAS RELATED TO AN ELEVATED INTERNATIONAL NORMALIZED RATIO OF 4.9. NO OTHER SOURCE OF BLEEDING WAS IDENTIFIED. THE PATIENT WAS TREATED WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS) AND THE PATIENT'S DAILY DOSE OF COUMADIN WAS REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200103 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7666872 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization