BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10618294 · Received October 1, 2020

    Report

    Report Number
    2916596-2020-04691
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 17, 2019
    Report Date
    November 13, 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 D4: CORRECTION SECTION H4: ADDITIONAL INFORMATION 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. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-003076 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE PERCUTANEOUS LEAD WERE ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 12JAN2016. 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 STARTING (B)(6) 2019. PATIENT WAS IN THE OUTPATIENT AREA WHEN IT WAS NOTICED THAT PATIENT HAD A DECREASE IN GENERAL CONDITION AND WAS ADMITTED WHERE THE CONTROL SHOWED A GI (GASTROINTESTINAL) BLEED WITH NEW MELENA. SUBSEQUENTLY, COAGULATION FACTORS WERE SUBSTITUTED IN THE FORM OF HAEMATES, ERYTHROCYTE CONCENTRATES AND FRESH FROZEN PLASMAS (FFPS). THIS TREATMENT STOPPED THE BLEEDING AND THE PATIENT RECOVERED SIGNIFICANTLY IN GENERAL CONDITION. LAST MEASURED HEMOGLOBIN (HB) WAS 9.5 G/DL. THE BLEEDING STOPPED AND NO FURTHER GASTROENTEROLOGICAL CLARIFICATION WAS NECESSARY. INR (INTERNATIONAL NORMALIZED RATIO) WAS 1.84, AND APTT WAS 32 AT TIME OF HOSPITALIZED. INR WAS 1.78 AND APTT WAS 29 AT TIME OF DISCHARGE ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075845 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 6067843

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization