BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2912117 · Received January 11, 2013

    Report

    Report Number
    2953200-2013-00069
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    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). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION, ENDOLEAK, ANEURYSM RUPTURE), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, AORTIC NECK DILATATION). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, AORTIC NECK DILATATION).

    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 10 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A RUPTURED AAA APPROXIMATELY ONE MONTH AGO. IMAGING DEMONSTRATED THE PROXIMAL CUFF (B)(4) WAS APPROXIMATELY 2CM BELOW THE RIGHT RENAL ARTERY AND THERE WAS A PARTIAL COMPONENT SEPARATION OF THE BIFURCATED DEVICE AND PROXIMAL EXTENSION CUFF. THE AORTIC NECK WAS DILATED AND MEASURED 28 MM IN DIAMETER AT THE RENAL ARTERIES. A 36X36X49 ENDURANT CUFF WAS PLACED TO RESOLVE THE TYPE IA ENDOLEAK AND TWO 16X16X93MM ENDURANT LIMBS WERE PLACED IN EACH LIMB TO RESOLVE BILATERAL TYPE III ENDOLEAKS. FINAL IMAGES DEMONSTRATED NO EVIDENCE OF ANY ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: AFTER THE IMPLANTATION OF THE AORTIC CUFF THE ANGIOGRAM REVEALED THAT THERE WAS A GOOD SEAL AT THE RENAL ARTERIES BUT THERE WAS STILL AN ENDOLEAK. THE ANGIOGRAM REVEALED THAT THERE WAS ALSO A TYPE III ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT AND THE PROXIMAL AORTIC CUFF, WHICH WAS NOT NOTICED ON THE RECENT CT SCAN. SINCE THE TYPE III ENDOLEAK WAS NOT APPARENT ON THE RECENT CT SCAN, THE ENDURANT AORTIC CUFF WAS NOT LONG ENOUGH TO COVER THE TYPE III ENDOLEAK BETWEEN THE ANEURX AORTIC CUFF AND THE ANEURX BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO IMPLANT TWO 16X16X93MM ENDURANT LIMBS, SIDE BY SIDE ABOVE THE FLOW DIVIDER INSIDE THE ANEURX BIFURCATED STENT GRAFT, WHICH BRIDGED THE ENDURANT AORTIC CUFF TO THE ANEURX BIFURCATED STENT GRAFT. THERE WERE NO ENDOLEAKS IN THE ILIAC LIMBS AND THE ILIAC STENT GRAFTS DID NOT REQUIRE INTERVENTION. THE FINAL ANGIOGRAM REVEALED THAT THE MIGRATION AND THE TYPE I AND TYPE III ENDOLEAKS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17706 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M02F552639

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention