BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11655061 · Received April 13, 2021

    Report

    Report Number
    2916596-2021-01896
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    February 28, 2021
    Report Date
    April 13, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BLEEDING COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES, AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PUMP SHIPPED ON 27AUG2020. 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. 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 HAD 2 TOOTH EXTRACTIONS ON (B)(6) 2021 WHICH LED TO BLEEDING FROM EXTRACTION SITE. WARFARIN, COUMADIN AND STUDY MEDICATION WERE HELD FROM (B)(6) 2021 TO (B)(6) 2021. THIS WAS RESUMED ON (B)(6) 2021. PATIENT WAS SEEN ON (B)(6) 2021 IN THE EMERGENCY DEPARTMENT WITH UNCONTROLLED BLEEDING FROM THE EXTRACTION SITE. PATIENTS HEMOGLOBIN WAS AT 10.6/32.8 AND INTERNATIONAL NORMALIZED RATIO AT 2 ON (B)(6) 2021. PATIENT WAS EXAMINED BY DENTIST AND FOUND A LARGE CLOT OVER THE AREA WITH NOTHING TO CAUTERIZE. LABS WERE REQUESTED ON (B)(6) 2021. BLEEDING STOPPED AND PATIENT IS DOING WELL. PATIENT MAINTAINS ON WARFARIN AND STUDY MEDICATION. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. IT WAS REPORTED THE BLEEDING WAS POSSIBLY DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554627 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7619733 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R