BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10774631 · Received November 2, 2020

    Report

    Report Number
    2916596-2020-05205
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    September 20, 2016
    Report Date
    December 1, 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORT OF MAJOR BLEEDING COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. IN ADDITION, A DIRECT CORRELATION WITH HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), COULD NOT BE CONCLUSIVELY ESTABLISHED. THE PATIENT REMAINS ONGOING ON (B)(6) FOLLOWING THIS EVENT; HOWEVER, THE PATIENT EXPERIENCED AN ADDITIONAL BLEEDING EVENT IN (B)(6) 2018 (REFERENCE MFR. REPORT # 2916596-2018-05196). THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Description of Event or Problem · 0

    THE BLEEDING WAS MEDIASTINAL AND UNSPECIFIC. THE PATIENT HAD NO SPECIFIC SYMPTOMS. THE PATIENT WAS TREATED WITH A BLOOD TRANSFUSION AND SURGERY DUE TO PERICARDIAL FLUID ON (B)(6) 2016. THE ACCOUNT CHANGED THE PATIENT'S ANTICOAGULATION THERAPY. THE DEVICE OPERATED AS EXPECTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 HAD MAJOR BLEEDING ON (B)(6) 2016. THE PATIENT HAD DECREASED HEMOGLOBIN ON (B)(6) 2016 AND WAS GIVEN 1 UNIT OF PACKED RED BLOOD CELLS (PRBC). THE PATIENT'S NUMBERS WERE HEMOGLOBIN 7.2 G/DL, QUICK 80%, INTERNATIONAL NORMALIZED RATIO (INR) 1.09, PROTHROMBLASTIN TIME 94 SECONDS, THERAPY. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2016 DUE TO PERICARDIAL FLUID. THE PATIENT RECEIVED ANOTHER 6 UNITS OF PRBC ON (B)(6) 2016 WITH THE FOLLOWING NUMBERS: HEMOGLOBIN 7.9 G/CL, QUICK 26%, INR 2.43, PTT 47 SECONDS. THE EVENT RESOLVED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239558 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 5502819

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R