BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4233327 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02347
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS REPORTED TO BE SHORT AND SLIGHTLY ANGULATED WITH OFFSED RENAL ARTERIES. THE PROXIMAL NECK DIAMETER WAS 24.2 MM, THE DISTAL NECK DIAMETER WAS 25 MM, THE NECK LENGTH WAS 12 MM, WITH AN ANGLE OF 14.2 DEGREES. IT WAS REPORTED THAT THE STENT GRAFT WAS IMPLANTED. A TYPE IA ENDOLEAK WAS SEEN AFTER DEPLOYMENT, SO AN ENDURANT II 32X32X49 AORTIC CUFF WAS IMPLANTED, AND THE LEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712874 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04170641

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention