BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2922582 · Received January 18, 2013

    Report

    Report Number
    2953200-2013-00118
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ANEURYSM RUPTURE).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE PHYSICIAN ELECTED TO IMPLANT ILIAC LIMBS BILATERALLY AS A PROPHYLACTIC MEASURE. THE CAUSE OF THE STENT GRAFT MIGRATION, TYPE I ENDOLEAK WHICH RESULTED IN ANEURYSM RUPTURE WAS RELATED TO THE SEVERE AORTIC NECK ANGULATION. IT IS UNKNOWN IF THE AORTIC NECK ANGULATION WAS AT THE TIME OF IMPLANT OR IF IT WAS DISEASE PROGRESSION.

    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 52 MONTHS AGO. ANEURYSM MORPHOLOGY FROM THE TIME OF IMPLANT IS UNKNOWN. THE PATIENT HAS AN ANGULATED AORTIC NECK. AN ANEURX BIFURCATED STENT GRAFT BFXCH2414165, AN AORTIC CUFF AEXCH282840, AN IEXCH182485 AND AN ILXCH1616135 WERE IMPLANTED AND THERE WERE NO COMPLICATION SINCE THE TIME OF IMPLANT. IT WAS REPORTED THAT APPROXIMATELY FOUR WEEKS AGO THE PATIENT PRESENT EMERGENTLY WITH PAIN AND A CT SCAN WAS DONE WHICH REVEALED A RUPTURE. THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE MIGRATED 4 CM WITH A PROXIMAL TYPE I ENDOLEAK PRESENT. AN ENDURANT AORTIC CUFF ETCF2828C49E AND AN ETEW2828C82E WERE IMPLANTED TO RESOLVE PROXIMAL TYPE I ENDOLEAK AND ANEURYSM RUPTURE. THE POSSIBLE CAUSE OF THIS EVENT WAS LIKELY DUE TO THE STENT GRAFT MIGRATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27825 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00089135

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention