BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2925758 · Received January 22, 2013

    Report

    Report Number
    2953200-2013-00140
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY, THE PROXIMAL AORTIC NECK IS 27.6 MM IN DIAMETER AND THE LEFT RENAL ARTERY IS LOWER THAN THE RIGHT. IT WAS REPORTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK DETECTED ON A FOLLOW-UP CT SCAN CLOSE TO RIGHT RENAL ARTERY. THE DECISION WAS MADE TO IMPLANT AN ENDURANT AORTIC CUFF PROXIMAL TO THE AUI STENT GRAFT TO ADDRESS THE PROXIMAL TYPE I ENDOLEAK. AFTER THE AORTIC CUFF WAS IMPLANTED, THE DELIVERY SYSTEM WAS PUSHED PROXIMALLY TO RECAPTURE THE TIP; HOWEVER, THE TOP CAP GOT CAUGHT ON THE SUPRARENAL STENTS. MINIMAL FORCE WAS USED TO ATTEMPT TO RELEASE THE STENT GRAFT, FOLLOWED BY COUNTER-CLOCKWISE TURN OF THE DEPLOYMENT HANDLE TO RECAPTURE PROXIMAL TO THE SUPRARENAL FIXATION STENTS BUT THE DELIVERY SYSTEM CAUGHT ON SUPRARENAL STENTS. THE TOP CAP WAS THEN RELEASED AND RECAPTURED, AND ON THE THIRD ATTEMPT, THE DELIVERY SYSTEM WAS ABLE TO BE PULLED INTO THE BODY OF THE STENT GRAFT AND REMOVED FROM THE PATIENT. AT THAT POINT, IT WAS NOTED THAT THE STENT GRAFT MOVED PROXIMALLY 3-4 MM AND PARTIALLY COVERED THE LEFT RENAL ARTERY. THERE WAS SOME BLOOD FLOW TO THE LEFT RENAL ARTERY; HOWEVER, IT TOOK OVER 90 MINUTES OF FLURO TIME TO ACHIEVE ACCESS VIA WIRE TO THE LEFT RENAL ARTERY. A 7 MM BALLOON EXPANDABLE STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY WITH MINIMAL OVERHANG INTO THE ABDOMINAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THIS DEVICE IS NOT APPROVED IN THE UNITED STATES HOWEVER IT IS SIMILAR TO AN ENDURANT BIFURCATED STENT GRAFT THAT IS APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29271 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1