BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8149448 · Received December 10, 2018

    Report

    Report Number
    2916596-2018-05454
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 24, 2018
    Report Date
    December 10, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4). APPROXIMATE AGE OF DEVICE - 1 YEAR, 9 MONTHS. 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. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. THE PATIENT HAD BEEN CONSTIPATED FOR 4 DAYS AND FINALLY HAD A BOWEL MOVEMENT WITH NO BLOOD IN STOOLS. ON ADMISSION TO THE EMERGENCY DEPARTMENT HEMOGLOBIN WAS 6.8 G/DL (DOWN FROM 7.2 G/DL) WITH INR OF 3.4. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TRANSFUSED WITH 1 UNIT OF PACKED RED BLOOD CELLS. THE GASTROENTEROLOGIST SAW THE PATIENT AND RECOMMENDED OUTPATIENT FOLLOW-UP TO PERFORM A CAPSULE ENTEROSCOPY SINCE HEMOGLOBIN WAS STABLE ON (B)(6) 2018 AND IN FACT HAD INCREASED FROM 7.3 TO 7.7 G/DL. THE PATIENT WAS DISCHARGED HOME WITHOUT ANY ASPIRIN OR COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985828 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 5718485

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R