BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2990398 · Received March 5, 2013

    Report

    Report Number
    2953200-2013-00410
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (SURGICAL REPAIR).

    Additional Manufacturer Narrative · 1

    RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (HIGH ILIAC LIMB ANGULATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (HIGH ILIAC LIMB ANGULATION).

    Description of Event or Problem · 1

    FROM THE EXAMINATION OF THE RETURNED DEVICE, THE CAUSE OF THE STENT GRAFT MIGRATION AND RESULTING PROXIMAL TYPE I ENDOLEAK COULD NOT BE DETERMINED. IT APPEARS THAT THE REPORTED DISEASE PROGRESSION WITH AORTIC PROXIMAL NECK DILATATION CAUSED THESE EVENTS. A SINGLE STENT FRACTURE WAS SEEN IN THE BIFURCATE PROXIMAL SEALING ZONE (RING 2); HOWEVER, IT IS NOT LIKELY THAT THIS FRACTURE CONTRIBUTED TO THE STENT GRAFT MIGRATION. FIVE ADDITIONAL FRACTURES WERE SEEN IN RING 3 NEAR THE FLOW DIVIDER. THE CAUSE OF THE FRACTURES COULD NOT BE DETERMINED (THE BIFURCATE AORTIC BODY WAS RETURNED ESSENTIALLY STRAIGHT) AND MAY HAVE OCCURRED AFTER THE DEVICE HAD MIGRATED INTO THE ANEURYSM SAC. THREE ABRASION HOLES (0.42 - 0.48MM²) AND ASSOCIATED MULTIPLE SUTURE BREAKS WERE OBSERVED IN THE MID-LENGTH OF THE IPSILATERAL LIMB BETWEEN RINGS 12 - 14. THESE FINDINGS WERE LIKELY CAUSED BY HIGH ILIAC LIMB ANGULATION, AND MAY HAVE ALSO OCCURRED AFTER THE DEVICE HAD MIGRATED. THERE WAS NO REPORT OF ANY ENDOLEAK IN THIS LOCATION, AND THE HOLES APPEARED COVERED BY TISSUE/THROMBUS IN THE 'AS RECEIVED' CONDITION; THEREFORE, IT IS UNLIKELY THAT THESE HOLES CONTRIBUTED TO ANY CLINICAL SEQUELAE. NO OTHER DEVICE INTEGRITY ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY FIVE YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE STENT GRAFT HAS MIGRATED INTO THE ANEURYSM SAC RESULTING IN PROXIMAL TYPE I ENDOLEAK; DUE TO DILATION OF THE PROXIMAL AORTIC NECK. THE PHYSICIAN DID NOT ATTEMPT REPAIR THE STENT GRAFT MIGRATION ENDOVASCULARLY AS THE AORTIC NECK HAD GROWN TOO MUCH PROXIMALLY TO ACHIEVE A SEAL. THE STENT GRAFTS WERE EXPLANTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93653 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR 810434

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention