BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2925746 · Received January 22, 2013

    Report

    Report Number
    2953200-2013-00139
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ARTERIAL OCCLUSION, INACCURATE STENT GRAFT DEPLOYMENT, REMOVAL DIFFICULTY). LACK OF INFORMATION (UNKNOWN CAUSE OF REMOVAL DIFFICULTY). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF REMOVAL DIFFICULTY).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS LOOSE WITHIN THE ORIGINAL PRODUCT BOX AND IT WAS BLOODIED. THE TAPERED TIP WAS 6 MM FROM THE GRAFT COVER. THE THUMB WHEEL WAS 9 MM FROM THE STARTING POSITION. THE GRAFT COVER WAS STRAIGHT WITHOUT ANY SIGNIFICANT KINKS; HOWEVER THERE WAS A MINOR KINK IN THE GRAFT COVER IMMEDIATELY FOLLOWING THE STRAIN RELIEF. THERE WAS A MINOR KINK IN THE STRAIN RELIEF AT THE FRONT GRIP. NEITHER OF THESE KINKS SHOULD HAVE IMPACTED DEVICE PERFORMANCE AND MAY HAVE OCCURRED DURING SHIPPING (SINCE THE DEVICE WAS RETURNED LOOSE IN THE BOX WITHOUT A TRAY). THE THUMBWHEEL ROTATED EASILY AND WAS RETURNED TO THE STARTING POSITION WITHOUT RESISTANCE. ONCE THE THUMBWHEEL WAS RETURNED TO THE STARTING POSITION, THERE WAS NO LONGER A GAP BETWEEN THE TAPERED TIP AND GRAFT COVER. THE BLUE EXTERNAL SLIDER HANDLE ROTATED SMOOTHLY WITHOUT RESISTANCE; THE QUICK RELEASE TRIGGER ALSO FUNCTIONED NORMALLY. THERE WAS NO DAMAGE TO THE TAPERED TIP, SLEEVE OR SPINDLE; THE DEVICE WAS UNREMARKABLE. THE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED; THE DEVICE WAS UNREMARKABLE AND FUNCTIONED AS INTENDED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29269 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00966662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention