BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3011684 · Received March 19, 2013

    Report

    Report Number
    2953200-2013-00486
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: (FILM). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT MIGRATION, ENDOLEAK, STENT GRAFT KINK, OCCLUSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (HIGHLY ANGULATED AORTIC NECK). UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH AN AORTIC NECK > 60 DEGREES). EVALUATION C CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (HIGHLY ANGULATED AORTIC NECK). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH AN AORTIC NECK > 60 DEGREES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 20 MONTHS AGO. THE AORTIC NECK ANGULATION WAS 90 DEGREES. IT WAS REPORTED THAT (B)(6) 2013- DURING A ROUTINE FOLLOW-UP CT SCAN IT WAS DISCOVERED THE STENT GRAFT WAS OCCLUDED. UPON REVIEW OF THE SCAN THE STENT GRAFT WAS FOUND KINKED DUE TO HIGHLY ANGULATED AORTIC NECK. THE PATIENT IS BEING MONITORED. REVIEW OF RETURNED FILMS POST-IMPLANT SHOW THE PROXIMAL STENT GRAFT MARGIN IS APPROXIMATELY 2CM BELOW THE RENAL ARTERIES, LIKELY HAS MIGRATED, AND THERE IS A PROXIMAL TYPE I ENDOLEAK. THE AAA MAX DIAMETER IS 10CM. THE PROXIMAL NECK IS ANGULATED 100DEG (A-P) AND 90DEG (L-R). THE STENT GRAFT IS KINKED APPROXIMATELY 6CM BELOW THE PROXIMAL END OF THE AUI, AND THERE IS CONSIDERABLE THROMBUS WITHIN THE STENT GRAFT ABOVE THE KINK. THE DISTAL LIMB APPEARS TO HAVE GOOD RUNOFF AND NO THROMBUS. IT IS LIKELY THAT THE HIGHLY ANGULATED NECK CONTRIBUTED TO THE STENT GRAFT KINK WHICH LED TO THE OCCLUSION. ANGIO IMAGES FROM A POSSIBLE TPA PROCEDURE SHOWS THE STENT GRAFT KINKED IN THE SAME LOCATION AS PREVIOUS IMAGES; UNKNOWN HOW MUCH OCCLUSION IS WITHIN THE DEVICE AS CONTRAST STUDY IS NOT SEEN. BUBBLES (POSSIBLY TPA) ARE SEEN INJECTED INTO THE STENT GRAFT, DISTAL TO THE KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114110 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00550573

    Patients

    Seq Age Sex Outcome Treatment
    1