BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10918851 · Received November 30, 2020

    Report

    Report Number
    2916596-2020-05838
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    October 7, 2020
    Report Date
    December 15, 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

    SECTION H4: ADDITIONAL INFORMATION. SECTION D4: CORRECTED DATA. MANUFACTURER'S 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. 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.

    Additional Manufacturer Narrative · 1

    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 BETWEEN (B)(6) 2020. THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO (INR) OF 2.5, HEMOGLOBIN OF 8.3 G/DL, AND IRON 14 UG/L.A BLOOD TEST AT THE PATIENT'S FAMILY DOCTOR FOUND A LOW HEMOGLOBIN VALUE OF 8.5 G/GL. GASTROSCOPY FOUND EROSIVE GASTRITIS. A COLONOSCOPY FOUND SMALL POLYP BUDS. AN ACTIVE SOURCE OF BLEEDING COULD NOT BE FOUND. MOST LIKELY THE BLEEDING OCCURRED IN THE STOMACH AREA. THE PATIENT WAS PUT UNDER ORAL ANTICOAGULATION WITH WARFARIN AND ASPIRIN WHICH THE PATIENT HAD TO TAKE DUE TO THE MECHANICAL SUPPORT SYSTEM OF THE HEART. THE ASPIRIN WAS PAUSED. THE PATIENT HAD 4 DOSES OF IRON (III) INTRAVENOUSLY. THERAPY WAS SUPPLEMENTED WITH PROTON PUMP INHIBITOR. THE PATIENT WAS DISCHARGED ON (B)(6) 2020 IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384355 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 5502819

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization