BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2970546 · Received February 20, 2013

    Report

    Report Number
    2953200-2013-00306
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 18, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (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 7.5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW UP AND IT WAS NOTED THAT THE STENT GRAFT HAS MIGRATED 3 CM WITH ANEURYSM SAC ENLARGEMENT AND THERE WAS A POSSIBLE SLIGHT TYPE I ENDOLEAK. THE LEFT COMMON ILIAC IS ELONGATED 3 CM, WHICH WILL REQUIRE INTERVENTION WITH A CUFF. THE MIGRATION IS DUE TO DISEASE PROGRESSION. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. REVIEW OF RETURNED FILMS POST-IMPLANT SHOW THAT THE IPSILATERAL LIMB WAS PLACED IN THE RIGHT ILIAC; THE CONTRALATERAL LIMB CROSSED OVER THE IPSILATERAL LIMB AND LANDED IN THE LEFT ILIAC. THE PROXIMAL NECK WAS ANGULATED 90DEG A-P AND 50DEG L-R, AND THE DIAMETER WAS 31 X 47MM JUST BELOW THE LOWEST RIGHT RENAL. THE BIFURCATED DEVICE WAS IN THE SAC; APPROXIMATELY 4CM BELOW THE RENALS. THERE WAS A LIKELY PROXIMAL TYPE I ENDOLEAK, BUT UNKNOWN IF CONTAINED BY THROMBUS AND IF PRESSURIZING THE 7.5CM AAA. EARLIER FOLLOW-UP FILMS WERE NOT PROVIDED. IT APPEARS THAT THE MIGRATION WAS DUE TO DISEASE PROGRESSION; NECK DILATATION AND ANGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74335 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR 552541

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR