BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 9439296 · Received December 9, 2019

    Report

    Report Number
    2916596-2019-05613
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    August 2, 2019
    Report Date
    February 28, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS AND THE REPORTED BLEEDING COULD NOT CONCLUSIVELY BE DETERMINED. THE ACCOUNT COMMUNICATED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6)2019 AFTER REPORTS OF WEAKNESS, DEFEAT, AND DYSPNEA. THE PATIENT REPORTEDLY HAD LOW HEMOGLOBIN. THE PATIENT CONTINUES TO REJECT A COLONOSCOPY AND A BLEEDING SOURCE WAS NOT DETERMINED. THE PATIENT WAS REPORTEDLY STABLE AFTER RECEIVING A TRANSFUSION. THIS EVENT WAS DETERMINED TO BE RESOLVED ON (B)(6)2019. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AS AN ADVERSE THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE AND PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND DYSPNOEA. THE PATIENT WAS HOSPITALIZED, THE PATIENT REJECTED A COLONOSCOPY. THE BLEEDING SOURCE WAS NOT LOCATED. THE PATIENT RECEIVED A BLOOD TRANSFUSION ("2 EK"). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230857 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6067843

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R