BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010487 · Received March 1, 2011

    Report

    Report Number
    2953200-2011-00575
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    December 22, 2010
    Report Date
    October 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ARTERIAL/VESSEL OCCLUSION, MODERATELY TORTUOUS VESSELS. EVALUATION, CONCLUSION: MODERATELY TORTUOUS VESSELS.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 6.3 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 30 MM DIAMETER X 58 MM LENGTH RIGHT ILIAC ARTERY ANEURYSM APPROXIMATELY NINE MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTIC NECK IS 31 MM IN DIAMETER, THE ACCESS VESSELS ARE 15 MM IN DIAMETER AND MODERATELY TORTUOUS BILATERALLY. IT WAS REPORTED THAT THE ENDURANT STENT GRAFTS WERE SUCCESSFULLY IMPLANTED PERCUTANEOUSLY WITHOUT COMPLICATION. IT WAS REPORTED THAT THERE WAS AN OCCLUSION OF THE STENT GRAFTS 6 MONTHS POST STENT GRAFT IMPLANT. THE PHYSICIAN ELECTED TO PERFORM AN AXILLI-BI-FEMORAL BYPASS. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE PROCEDURE, BUT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. (REF MFR# 2953200-2011-00572, 2953200-2011-00573, 2953200-2011-00574).

    Description of Event or Problem · 1

    FILMS WERE RECEIVED AND THEIR EVALUATION WAS COMPLETED INTERNALLY. THE FILMS AT THE TIME OF IMPLANT SHOW THAT THE ENDURANT AUI STENT GRAFT WAS IMPLANTED FOR REPAIR OF ANOTHER MANUFACTURER'S BIFURCATED STENT GRAFT. THE CONTRALATERAL GATE OF THE BIFURCATED STENT GRAFT WAS OPEN. THE CONTRA LIMB WAS SEEN WITHIN THE SAC. AFTER IMPLANT OF THE AUI STENT GRAFT THERE WERE NO ISSUES OBSERVED. THERE WAS AN ACUTE BEND OF THE EXTERNAL ILIAC ARTERY, DISTAL TO THE STENT GRAFT, WHICH MAY HAVE CONTRIBUTED TO THE OCCLUSION SEEN AT 6 MONTHS. THE REPORTED OCCLUSION COULD NOT BE EVALUATED AS FILMS FROM THIS EVENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00317735

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention