BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8297081 · Received February 1, 2019

    Report

    Report Number
    2916596-2019-00470
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 17, 2018
    Report Date
    April 5, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED BLEEDING EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT¿S HEMOGLOBIN (HGB) WAS AT 6.7 G/L ON (B)(6) 2019. THE PATIENT WAS TRANSFUSED TWO UNITS OF PACKED RED BLOOD CELLS (PRBCS), AND PHG WAS ON THE RISE. THE PATIENT REPORTEDLY HAD CONSISTENT LOW HGB, AND POSSIBLE CHRONIC ANEMIA. NO DIAGNOSTIC TESTS WERE PERFORMED, AND THE SITE OF BLEEDING WAS NOT DETERMINED AS IT WAS THOUGHT THE PATIENT HAS CHRONIC ANEMIA. THE PATIENT WAS BEING REFERRED TO GI. AFTER THE TRANSFUSION, THE PATIENT¿S HEMODYNAMICS WERE STABLE AND THERE WAS NO SIGN OF ACTIVE BLEED BY (B)(6) 2019. 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 REPORTED EVENT AND SUBSEQUENT INVESTIGATION DO NOT INDICATE AN ISSUE WITH THE MANUFACTURE OF THE PRODUCT. THE PATIENT REMAINS ONGOING ON THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THE EVENT.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23AUG2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE 3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE: 1 YEAR AND 1 MONTH. 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

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 WITH LOW HEMOGLOBIN. NO DIAGNOSTIC TESTS WERE PERFORMED AND THE ACCOUNT REPORTED NO ACTIVE BLEEDING. THE ACCOUNT BELIEVED THE PATIENT'S SYMPTOMS TO BE ASSOCIATED WITH CHRONIC ANEMIA. THE PATIENT RECEIVED 2 UNITS OF PACKED RED BLOODS CELLS IN A 24 HOUR PERIOD. PER THE ACCOUNT, THE PATIENT WAS REFERRED TO GASTROINTESTINAL (GI) AND IS HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90718 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 5932323

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R