BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3201505 · Received July 2, 2013

    Report

    Report Number
    2953200-2013-01236
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 25, 2006
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: STILL IMAGES. RESULTS: ENDOLEAK. LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. FIVE MONTHS AFTER THE INDEX PROCEDURE AN ANEURX CUFF WAS IMPLANTED FOR THE TREATMENT OF A POSSIBLE TYPE I ENDOLEAK. APPROXIMATELY FIVE YEARS LATER A TALENT STENT GRAFT WAS IMPLANTED FOR THE INTERVENTION OF A POSSIBLE TYPE III ENDOLEAK (SEPARATION). ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT SCAN REVEALED THE PRESENCE OF A POSSIBLE TYPE I, III OR IV ENDOLEAK. THE PHYSICIAN NOTED THAT THE STENT GRAFT (MAIN BODY) WAS IN THE ORIGINAL LOCATION WITH NO SIGNS OF MIGRATION. THE PATIENT IS CURRENTLY ON DIALYSIS. THE PHYSICIAN MENTIONED THAT THE ONLY OPTION FOR THE PATIENT WAS TO PLACE AN ENDURANT AUI STENT GRAFT ALL THE WAY UP TO THE SMA AND COVER BOTH RENAL ARTERIES. AT THE END OF THE PROCEDURE A FEM-FEM BYPASS WAS PERFORMED AND THE FINAL ANGIOGRAM SHOWED NO ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. A REVIEW OF SEVERAL RETURNED STILL IMAGES SHOW AN UNKNOWN TYPE ENDOLEAK NEAR THE BIFURCATE FLOW DIVIDER ON THE RIGHT SIDE, AND NEAR THE GATE. POST AUI IMPLANT IMAGE SHOWED THAT THE AUI WAS IMPLANTED NEAR THE RENALS/SMA, THROUGH THE LEFT SIDE. MULTIPLE COILS WERE SEEN PLACED INSIDE THE RIGHT/IPSILATERAL LIMBS. NO ENDOLEAK WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303147 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 675446

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention