BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3191714 · Received June 26, 2013

    Report

    Report Number
    2953200-2013-01206
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM EVALUATION. RESULTS: OCCLUSION. ANATOMY RELATED, SEVERELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. CONCLUSION: OCCLUSION. ANATOMY RELATED, SEVERELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 19 MM IN DIAMETER AND 25 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 19 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 14 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 9 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 9 MM IN DIAMETER. AT THE INDEX PROCEDURE THE PHYSICIAN COILED THE RIGHT INTERNAL ILIAC ARTERY AND THEN IMPLANTED THE ENDURANT STENT GRAFTS. THE RIGHT LIMB WAS EXTENDED TO THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGHT LIMB WAS OCCLUDED. THE PHYSICIAN PERFORMED A THROMBECTOMY AND IMPLANTED A BARE STENT IN THE RIGHT LIMB. THE PHYSICIAN STATED THAT THE PATIENT HAD TORTUOSITY OF THE VESSEL AND THERE WAS A POSSIBILITY THAT THE RIGHT LIMB BENT DUE TO VESSEL TORTUOSITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF RETURNED FILMS 7 DAYS POST-IMPLANT SHOWED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENAL ARTERIES. THE AAA MAX DIAMETER WAS 9CM. THE IPSILATERAL LIMB AND 10MM DIAMETER EXTENSION WERE PLACED WITHIN THE RIGHT COMMON ILIAC (ONLY APPROXIMATELY 2CM DISTAL SEAL); THE ID OF THE DISTAL RIGHT LIMB WAS 6-9MM. THE CONTRALATERAL LIMB AND 24MM EXTENSION WERE WITHIN THE FULL LENGTH OF THE LEFT COMMON ILIAC ARTERY. JUST DISTAL TO THE STENT GRAFT LIMBS THE EXTERNAL ILIAC ARTERIES WERE SEVERELY TORTUOUS; BILATERALLY. NO THROMBUS OR ANY OTHER STENT GRAFT ISSUES WERE SEEN. FILMS 3 WEEKS POST-IMPLANT SHOW THAT THE IPSILATERAL (RIGHT) STENT GRAFT COMPONENTS WERE OCCLUDED, BEGINNING JUST BELOW THE BIFURCATE FLOW DIVIDER. NO THROMBUS WAS SEEN WITHIN THE CONTRALATERAL STENT GRAFT LIMBS. NO OBVIOUS CHANGE IN STENT GRAFT IN-VIVO CONFIGURATION WERE SEEN AS COMPARED TO THE EARLIER POST-IMPLANT STUDY. NO STENT GRAFT KINKS WERE OBSERVED. THE ID OF THE DISTAL RIGHT LIMB VARIED FROM 6-8MM. THE EXACT CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE SEVERELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY JUST DISTAL TO THE RIGHT LIMB MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290182 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03991757

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention