BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3020084 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00534
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    November 5, 2012
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHODS: (FILMS). EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (FLOW LUMEN REDUCTION WITHIN THE OVERLAPPING STENT GRAFTS; SMALL AND CALCIFIED DISTAL AORTA COMPRESSING STENT GRAFT LIMBS). EVALUATION CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (FLOW LUMEN REDUCTION WITHIN THE OVERLAPPING STENT GRAFTS; SMALL AND CALCIFIED DISTAL AORTA COMPRESSING STENT GRAFT LIMBS).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT OCCLUSION. STENT GRAFT WAS OVERSIZED. CONCLUSION: 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 APPROXIMATELY NINE MONTHS AGO. IT WAS REPORTED THAT AN EMBOLECTOMY WAS DONE IN THE LEFT POPLITEAL ARTERY APPROXIMATELY SIX MONTHS POST IMPLANT. AT THAT TIME AN OCCLUSION IN THE STENT GRAFT WAS ALSO OBSERVED IN THE AREA WHERE THE LEFT CONTRALATERAL LIMB OVERLAPPED WITH THE STENT GRAFT. THE POSSIBLE CAUSE OF THIS OCCLUSION MAY BE THE OVERLAPPING OF 16MM DIAMETER STENT GRAFTS IN A 12MM ARTERY. THE PATIENT HAS NO HISTORY OF OTHER COAGULATION PROBLEMS. APPROXIMATELY ONE MONTH LATER THE STENT GRAFTS WERE EXPLANTED AND REPLACED WITH A CONVENTIONAL PROSTHESIS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN: THE SURGICAL CONVERSION WAS DONE BECAUSE THERE WAS NOT ONLY AN OCCLUSION IN THE LIMB OF THE STENT GRAFT, BUT ALSO A MORE CRITICAL DISTAL OCCLUSION RESULTING FROM EMBOLISM. THE DEVICE WAS EXPLANTED DURING SURGICAL CONVERSION DUE TO STENT GRAFT OCCLUSION. THE PATIENT WAS INITIALLY TREATED FOR A 5.3CM INFRARENAL ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PROXIMAL NECK DIAMETER WAS 20 - 21MM X 20MM LONG, AND THE ILIAC ARTERY DIAMETERS WERE 13MM BILATERALLY. FOUR MONTHS POST-IMPLANT AN EMBOLECTOMY WAS DONE IN THE LEFT POPLITEAL ARTERY, AT WHICH TIME AN OCCLUSION WITHIN THE STENT GRAFT WAS OBSERVED IN THE AREA WHERE THE LEFT CONTRALATERAL LIMB WAS OVERLAPPING THE BIFURCATE GATE. THE DECISION MADE TO EXPLANT THE STENT GRAFT DURING OPEN REPAIR; THE PATIENT WAS SUCCESSFULLY CONVERTED. IT WAS REPORTED THAT THE PATIENT HAD NO HISTORY OF COAGULATION PROBLEMS, AND THE POSSIBLE CAUSE OF THE OCCLUSION MAY BE DUE TO OVERLAPPING OF THE 16MM STENT GRAFT LIMBS INTO THE 12MM ILIAC ARTERIES. FROM THE EXAMINATION OF THE RETURNED DEVICE AND CLINICAL INFORMATION PROVIDED, THE CAUSE OF THE STENT GRAFT OCCLUSION COULD NOT BE CONFIRMED. OTHER THAN SEVERAL FABRIC TEARS, LIKELY OCCURRING DURING THE EXPLANT OF THE DEVICE, NO DEVICE INTEGRITY ISSUES WERE OBSERVED. A POSSIBLE CONTRIBUTOR TO THE OCCLUSION MAY HAVE BEEN THE FLOW LUMEN REDUCTION WITHIN THE OVERLAPPING REGION OF THE 16MM OD CONTRALATERAL LIMB STENT GRAFT ALONG THE LENGTH OF THE GATE OF THE BIFURCATED STENT GRAFT. HOWEVER, THERE WAS NO APPRECIABLE DIFFERENCE OBSERVED BETWEEN THE DISTAL RUNOFF OF EITHER ILIAC LIMB AND DISTAL ARTERIES. IT IS ALSO POSSIBLE THAT THE SMALL AND CALCIFIED DISTAL AORTA MAY HAVE CONTRIBUTED TO THE OCCLUSION. ALTHOUGH NO THROMBUS WAS REPORTED IN THIS LOCATION, OR SEEN IN THE FILMS, SOME MINOR STENT GRAFT LIMB COMPRESSION IN THIS AREA WAS OBSERVED. THE STENT GRAFTS WERE VERIFIED TO HAVE MET ALL ENDURANT II MANUFACTURING SPECIFICATIONS PRIOR TO SHIPMENT, AND THE STENT GRAFT DIAMETER DIMENSIONS WERE CONFIRMED WITH BE WITHIN TOLERANCE. ONLY THE 23MM BIFURCATED STENT GRAFT HAS A 12MM DIAMETER GATE; ALL OTHER SIZES HAVE A 14MM GATE. PLACEMENT OF THE 16MM OD CONTRALATERAL LIMB IN THE 12MM GATE IS STANDARD PRACTICE, SUGGESTING OTHER FACTORS CONTRIBUTED TO THIS OCCLUSION. FILMS FROM PRE AND POST-IMPLANT WERE PROVIDED FOR REVIEW. PRE-IMPLANT IMAGES SHOWED A 5.3CM MAXIMUM DIAMETER AAA; THE PROXIMAL NECK AND AAA CONTAINED THROMBUS AND CALCIFICATION. THE DISTAL AORTA WAS SMALL AND SEVERELY CALCIFIED. IMAGES 2-WEEKS POST-IMPLANT SHOWED NO THROMBUS WITHIN THE STENT GRAFT, WITH NO VISIBLE STENT GRAFT KINKS OR ENDOLEAK. WITHIN THE GATE THE CONTRALATERAL (LEFT) LIMB ID NARROWS DOWN TO 9MM, AND JUST DISTAL TO THE GATE IT OPENS TO 15 - 16MM. THERE IS ALSO SOME MINOR LIMB COMPRESSION SEEN WITHIN THE DISTAL AORTA. MRI AND ANGIOGRAM IMAGES AT 4-MONTHS SHOWED DIMINISHED BLOOD FLOW (POSSIBLE THROMBUS) IN THE LEFT/CONTRALATERAL LIMB, WITHIN THE OVERLAPPING 3CM LENGTH SECTION OF THE GATE. THE FLOW CHANNEL OD MEASURES 8 - 9MM WITHIN THE GATE (COMPARED TO 12 - 13MM ON THE IPSILATERAL LIMB), AND DISTAL TO THE GATE THE ILIAC RUNOFF APPEARS NORMAL DISTALLY TO THE LEGS; BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121985 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01079158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention