BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3201296 · Received July 2, 2013

    Report

    Report Number
    2953200-2013-01230
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 28, 2013
    Report Date
    August 9, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PATIENT HISTORY OF FEMORAL ARTERY OCCLUSIVE DISEASE). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); DEVICE FAILURE RELATED TO PATIENT CONDITION (PATIENT HISTORY OF FEMORAL ARTERY OCCLUSIVE DISEASE).

    Additional Manufacturer Narrative · 1

    METHOD: FILM EVALUATION.

    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. ANEURYSM AND VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER HAVING 4 DAYS OF INCREASINGLY WORSE RIGHT FOOT ISCHEMIA. THE PATIENT WAS DIAGNOSED WITH AN AORTIC DISSECTION WITH SEVERE ILIAC OCCLUSIVE DISEASE IN A THROMBOSED RIGHT STENT GRAFT LIMB. CLOT WAS REMOVED; HOWEVER THERE WAS NO FLOW ACHIEVED. A 161093 WAS IMPLANTED AND THE PHYSICIAN PERFORMED A FEMORAL-FEMORAL BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ANGIOGRAM IMAGES FROM 6 MONTH FOLLOW UP SHOWED THAT THE BIFURCATE WAS IMPLANTED WITH THE IPSILATERAL LIMB ON THE RIGHT SIDE, AND SINGLE CONTRALATERAL LIMB ON THE LEFT. NO STENT GRAFT KINKS OR LARGE LIMB ANGULATIONS ARE SEEN. AFTER BALLOONING, THE IPSILATERAL LIMB THROMBUS WAS SEEN ALONG THE LENGTH OF THE IPSI/RIGHT LIMB. THE BLOOD FLOW THROUGH THE CONTRALATERAL LIMB COULD NOT BE ACCURATELY ASSESSED. BOTH LIMBS WERE THEN RE-LINED AT THE FLOW DIVIDER. THE FINAL ANGIOGRAM SHOWS GOOD FLOW IN BOTH LIMBS. A STENT WAS ALSO SEEN IN THE RIGHT EXTERNAL ILIAC. RECENT CTA'S SHOW THAT THE IPSILATERAL LIMB IS COMPLETELY OCCLUDED BEGINNING AT THE FLOW DIVIDER. THE CONTRALATERAL LIMB IS PATENT. THERE IS A FEM-FEM BYPASS VISIBLE. THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED; MAY BE PATIENT RELATED. THE REPORTED DISSECTION WAS NOT OBSERVED AND THE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303203 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01066846

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention