BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12664390 · Received October 20, 2021

    Report

    Report Number
    2916596-2021-05860
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    October 26, 2019
    Report Date
    December 14, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-003893 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ OUTLINES THE SUGGESTED ANTICOAGULATION REGIMEN AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE THAT SHOULD BE MAINTAINED FOR PATIENTS USING THE HEARTMATE 3 LVAS, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED BLEEDING COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE SITE OF BLEEDING WAS IDENTIFIED TO BE INTRA-ABDOMINAL. AFTER TREATMENT, THE BLEEDING RESOLVED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEMOGLOBIN LEVEL HAD FALLEN FROM 105 TO 76, WHICH WAS CONSISTENT WITH ACUTE BLEEDING. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.5 AT THE TIME. THE PATIENT'S PROTHROMBIN TIME RATIO WAS 1.3. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND TREATED WITH MEDICATION AND BLOOD TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565289 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 5473565

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Hospitalization| R