BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7739930 · Received August 1, 2018

    Report

    Report Number
    2916596-2018-03170
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    July 5, 2018
    Report Date
    December 19, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS 00813024013297. APPROXIMATE AGE OF DEVICE- 37 DAYS. MAIN INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR DEVICE (LVAD) ON IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COMPLAINTS OF WEAKNESS, DIZZINESS, SHORTNESS OF BREATH, ANEMIA, AND DARK STOOLS ON (B)(6) 2018. ON ADMISSION, THE PATIENT WAS TRANSFUSED WITH ONE UNIT OF PACKED RED BLOOD CELLS (PRBCS). THE ESOPHAGOGASTRODUODENOSCOPY (EGD) OBTAINED ON (B)(6) 2018 WAS NEGATIVE FOR BLEEDING. THE PATIENT WAS TRANSFUSED WITH A TOTAL OF TWO PACKED RED BLOOD CELLS (PRBCS) BETWEEN (B)(6) 2018. A COLONOSCOPY WAS PERFORMED ON (B)(6) 2018 BUT NO SOURCE OF BLEEDING WAS FOUND SO ASPIRIN AND COUMADIN WERE STOPPED. PATIENT IS STILL ON THE PUMP AND STABLE AND HAS BEEN RESTARTED ON COUMADIN DUE TO A LOW INTERNATIONAL NORMALIZED RATIO (IRD). NO OTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582244 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6407126

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R