BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3100646 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00864
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM. RESULTS: STENT GRAFT INFOLD. THROMBUS WITHIN THE AORTIC NECK. STENT GRAFT WAS OVERSIZED. CONCLUSION: STENT GRAFT INFOLDING. THROMBUS WITHIN THE AORTIC NECK. STENT GRAFT WAS OVERSIZED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM THAT WAS PREVIOUSLY TREATED WITH ANOTHER MANUFACTURER'S STENT GRAFT. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE OTHER MANUFACTURER'S STENT GRAFT MIGRATED; THEREFORE, THE PHYSICIAN IMPLANTED A 36 MM ENDURANT CUFF. THE PHYSICIAN THOUGHT THERE APPEARS TO BE INFOLDING OF THE ENDURANT CUFF AND TRIED TO CORRECT THAT WITH A PTA BALLOON. NO FURTHER INTERVENTION WAS PERFORMED. REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOW THAT THE PROXIMAL NECK DIAMETER (FLOW LUMEN) IS APPROXIMATELY 28-29MM JUST BELOW RENAL ARTERIES. FROM THE RIGHT SIDE THE ENDURANT CUFF WAS DEPLOYED BELOW THE RENAL ARTERIES WITHIN A PREVIOUSLY IMPLANTED STENT GRAFT FROM ANOTHER MANUFACTURER WHICH HAD MIGRATED INTO THE ANEURYSM SAC. THE CUFF OVERLAPPED THE OTHER MANUFACTURER'S STENT GRAFT BY 2-3CM. POST SUPRARENAL STENT DEPLOYMENT SHOWED THAT NO STENT ENTANGLEMENT WAS OBSERVED. SEVERAL OF THE SUPRARENAL STENT APICES APPEARED TO BE APPROXIMATELY 6-8MM DISTAL TO THE OTHER STENTS; NO OTHER STENT GRAFT OR BLOOD FLOW ISSUES WERE NOTED. SAME DAY POST-IMPLANT CTA'S SHOWED THAT THE CUFF WAS INFOLDED NEARLY IT'S ENTIRE LENGTH, BEGINNING AT THE PROXIMAL GRAFT MARGIN. NO SUPRARENAL STENT ENTANGLEMENT WAS NOTED. THE INFOLDING APPEARED TO HAVE SEPARATED THE TUBE INTO 2 SEPARATE FLOW CHANNELS. THE AORTIC NECK DIAMETER AT THE RENALS WAS 25 X 27MM AND CONTAINED THROMBUS. THE OUTER DIAMETER OF THE STENT GRAFT AT THE RENAL ARTERIES WAS 21 X 24MM, AND VARIED FROM 21MM - 26MM ALONG THE FULL LENGTH. THE ID OF THE OTHER MANUFACTURER'S AORTIC BODY VARIED FROM 24-28MM. JUST DISTAL TO THE CUFF, WITHIN THE THROMBUS FILLED AORTIC BODY OF THE OTHER MANUFACTURER'S STENT GRAFT, THE FLOW LUMEN MEASURED 18 X 22MM. NO OCCLUSION WAS OBSERVED FROM THE FLOW DIVIDER DISTALLY INTO BOTH LIMBS. THE CAUSE OF THE INFOLDING APPEARS TO BE DUE TO STENT GRAFT OVERSIZING WITHIN THE NECK WHICH CONTAINED THROMBUS. THROMBUS SEEN WITHIN THE PREVIOUSLY PLACED STENT GRAFT MAY HAVE ALSO CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201972 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR