BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 4131432 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01957
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. THE PATIENT PRESENTED EMERGENTLY WITH AN RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THE BIFURCATED STENT GRAFT HOWEVER THERE WAS A LARGE PROXIMAL TYPE I ENDOLEAK. AN ENDURANT AORTIC CUFF WAS THEN IMPLANTED PROXIMALLY HOWEVER THE ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN DECIDED TO CONVERT TO AN OPEN SURGICAL REPAIR. DURING THE OPEN REPAIR THE PATIENT EXPIRED. REVIEW OF RETURNED IMAGES PRE-IMPLANT REVEALED THAT THE PATIENT HAD AN HIGHLY ANGULATED (LIKELY OFF-LABEL) AND CALCIFIED PROXIMAL NECK. THE NECK DIAMETER WAS APPROXIMATELY 25MM. THE MAXIMUM AAA DIAMETER WAS 9CM, AND WAS RINGED WITH CALCIFICATION. THE DISTAL AORTA WAS SMALL AND THE ILIACS WERE ALSO CALCIFIED. THE CAUSE OF THE TYPE I ENDOLEAK COULD NOT BE DETERMINED. IMAGES DURING IMPLANT WERE NOT PROVIDED. THE PRE-IMPLANT IMAGES WERE NON-CONTRAST WHICH LIMITED THE EXTENT OF THE FILM REVIEW. IT IS POSSIBLE THAT THE CALCIFIED AND SEVERELY ANGULATED NECK MAY HAVE CONTRIBUTED TO THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611214 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04201318

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death| R