BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 10199615 · Received June 26, 2020

    Report

    Report Number
    9612164-2020-02331
    Event Type
    Death
    Date Received
    June 26, 2020
    Date of Event
    May 23, 2020
    Report Date
    July 24, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169439979
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED AS PER THE PHYSICIAN THAT THE BLOOD LOSS WAS NOT RELATED TO THE ENDOGRAFT, IT WAS REPORTED THE PATIENT POSSIBLY WENT INTO DIC, AS PER THE PHYSICIAN NONE OF THE IMPLANTED DEVICES OR PROCEDURE WERE RELATED TO THE BLOOD LOSS OR PT DEATH. CAUSE OF DEATH PER PHYSICIAN WAS HEMORRHAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ETLW1620C124E, SERIAL/LOT #: (B)(4), UBD: 11-FEB-2022, UDI#: (B)(4); PRODUCT ID: ETLW1620C124E, SERIAL/LOT #: (B)(4), UBD: 05-MAR-2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE FAMILY OF THE PATIENT WAS NOTIFIED THE NEXT DAY THAT THE PATIENT WAS LOSING A LOT OF BLOOD AND WOULD BE GOING BACK TO SURGERY. THE FAMILY WAS LATER INFORMED THAT THE PATIENT DIED FROM COMPLICATIONS. THE PATIENTS REGISTRATION CARD HAD A MISPRINT IN THE PATIENT'S DATE OF BIRTH. THE CAUSE OF THE EVENTS WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665219 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ESBF2814C103E 00643169439979

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death