BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3243870 · Received July 23, 2013

    Report

    Report Number
    2953200-2013-01419
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK) ; LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL ILIAC STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. A BIFURCATED STENT GRAFT WAS NO IMPLANTED. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PROXIMAL MAIN TUBE STENT GRAFT 202055 HAD MOVED DOWN SLIGHTLY DUE TO DISEASE PROGRESSION WITH A TYPE I ENDOLEAK PRESENT. THIS PATIENT WAS LOST TO FOLLOW-UP AND PRESENTED WITH BACK PAIN APPROXIMATELY 38 MONTHS POST IMPLANT. UPON EXAMINATION THERE WAS A DISTAL AORTA RUPTURE. IT WAS CONFIRMED THERE WAS A TYPE III ENDOLEAK IN THE DISTAL AORTA. THE RUPTURE WAS RESOLVED BY PLACEMENT OF AN ENDURANT BIFURCATED STENT GRAFT WITHIN THE EXISTING AORTIC TUBE GRAFT FOLLOWED BY PLACEMENT OF A P4010 PALMAZ STENT IN THE IPSILATERAL LIMB TO OCCLUDE THE CONTRALATERAL GATE TO CREATE AN AUI. THERE WAS A SMALL ENDOLEAK PRESENT AND THE DECISION WAS MADE TO RELINE THE ENTIRE IPSILATERAL LIMB WITH A 16X16X93 ENDURANT STENT GRAFT. FINAL SHOT DEMONSTRATED CHANNELING THE BLOOD FLOW TO THE RIGHT SIDE. ANOTHER MANUFACTURER'S OCCLUDER WAS PLACED IN THE INTERNAL COMMON ILIAC ARTERY. A FEM-FEM BYPASS WAS PERFORMED. ON FINAL ANGIOGRAM RUN THE ENDOLEAKS HAD RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF SEVERAL STILL ANGIO IMAGES SHOWED A LIKELY TYPE III FABRIC ENDOLEAK NEAR THE DISTAL AORTA. AFTER IMPLANTING AN ENDURANT BIFURCATE, AN ENDOLEAK WAS STILL SEEN IN THE DISTAL AORTA. AFTER RELINING THE IPSILATERAL LIMB THE ENDOLEAK APPEARED TO HAVE RESOLVED. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343265 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00993772

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention