BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3190571 · Received June 26, 2013

    Report

    Report Number
    2953200-2013-01199
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 24, 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: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); (CAUSE OF EVENT IS UNKNOWN); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NARROWING NEAR THE ILIAC BIFURCATION). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); (CAUSE OF EVENT IS UNKNOWN); DEVICE FAILURE RELATED TO PATIENT CONDITION (NARROWING NEAR THE ILIAC BIFURCATION).

    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 WAS NOT REPORTED. FOURTEEN DAYS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH COLD AND PAINFUL LEG. IT WAS LATE, SO THE PATIENT WENT HOME THAT DAY. LIMB OCCLUSION WAS OBSERVED. SEVENTEEN DAYS POST INDEX PROCEDURE THE PATIENT CAME TO THE HOSPITAL AGAIN AND AN ANGIOGRAM SHOWED A LEFT LIMB OCCLUSION. THE PHYSICIAN PERFORMED A THROMBECTOMY AND IMPLANTED A BARE METAL STENT. THE PHYSICIAN STATED THAT THE PATIENT WAS NOT A DIFFICULT CASE AND THE CAUSE OF THE OCCLUSION WAS UNKNOWN. THERE WAS NO PROBLEM ON VESSEL SIZE AND VESSEL TORTUOSITY. THE LEFT LIMB WAS IMPLANTED ABOVE THE INTERNAL ILIAC ARTERY AND THE DISTAL EDGE OF THE LEFT LIMB SLIGHTLY APPEARED TO BE INFOLDING. THERE WAS A POSSIBILITY OF ¿CROSS-LEG¿ BUT IT WAS UNCERTAIN. 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 IPSILATERAL LIMB AND EXTENSION WERE PLACED ON THE RIGHT SIDE, AND THE CONTRALATERAL LIMB AND EXTENSION ON THE LEFT. THE DISTAL ENDS OF EACH LIMB WERE PLACED JUST ABOVE THE ILIAC BIFURCATION. NO STENT GRAFT THROMBUS WAS OBSERVED. OTHER THAN MINOR STENT GRAFT COMPRESSION (8 - 9MM ID MINIMUM) SEEN WITHIN THE DISTAL AORTA OF BOTH THE IPSILATERAL AND CONTRALATERAL LIMBS, NO STENT GRAFT KINKS OR TWISTING WAS OBSERVED. THE FILMS 17 DAYS POST-IMPLANT SHOW THAT THE CONTRALATERAL (LEFT) STENT GRAFT COMPONENTS WERE OCCLUDED, BEGINNING JUST ABOVE THE BIFURCATE FLOW DIVIDER. NO THROMBUS WAS SEEN WITHIN THE IPSILATERAL STENT GRAFT LIMBS. NO OBVIOUS CHANGE IN STENT GRAFT IN-VIVO CONFIGURATION WAS SEEN AS COMPARED TO THE EARLIER POST-IMPLANT STUDY. FROM THE IMAGES PROVIDED THE REPORTED STENT GRAFT INFOLDING ALONG THE DISTAL CONTRA LIMB COULD NOT BE CONFIRMED OR RULED OUT. THE STENT GRAFT DIAMETER WITHIN THE LEFT COMMON ILIAC AND JUST PROXIMAL TO REPORTED INFOLDING MEASURED 9MM. THE NON-OCCLUDED IPSILATERAL LIMBS MEASURED 8-9MM WITHIN THE RIGHT ILIAC. THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE REPORTED CONTRA DISTAL STENT GRAFT INFOLDING, LIKELY DUE TO NARROWING NEAR THE ILIAC BIFURCATION, MAY HAVE CONTRIBUTED TO THE OCCLUSION. THE OCCLUSION MAY HAVE ALSO BEEN CAUSED BY A PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290939 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03995038

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention