BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3953842 · Received July 23, 2014

    Report

    Report Number
    2953200-2014-01451
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 50 MM FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY WAS 34MM. THE MINIMUM DIAMETER OF THE LEFT EXTERNAL ILIAC ARTERY WAS 4.6MM. IT WAS REPORTED THAT SEVEN DAYS POST IMPLANT THE PATIENT COMPLAINED OF LEG PAIN. A CT CONFIRMED THERE WAS NO BLOOD FLOW IN THE LEFT LIMB AND THE DECISION WAS MADE TO PERFORM A THROMBECTOMY PROCEDURE WITH A FOGARTY CATHETER AND PERCUTANEOUS BALLOON ANGIOPLASTY ON THE SAME DAY. ANOTHER MANUFACTURER¿S BARE METAL STENT WAS IMPLANTED BETWEEN THE DISTAL STENT GRAFT AND THE EXTERNAL ILIAC ARTERY. THE ORIGIN OF THE COMMON ILIAC ARTERY HAD SEVERE TORTUOSITY AND WAS ALMOST KINKED; THEREFORE, ANOTHER BARE METAL STENT WAS IMPLANTED. ANGIOGRAPHY SHOWED A TYPE III ENDOLEAK WHICH APPEARED TO HAVE BEEN CAUSED BY THE WIRE MANIPULATION DURING THE INTERVENTION PROCEDURE. ANOTHER MANUFACTURER¿S STENT GRAFT WAS IMPLANTED TO ADDRESS THE ENDOLEAK AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. THE PHYSICIAN COMMENTED THAT THE OCCLUSION MAY HAVE BEEN INDUCED BY KINKING DUE TO THE SEVERE CURVATURE OF THE ORIGIN OF THE COMMON ILIAC ARTERY AND IMPLANT OF THE STENT GRAFT BY 3 STENT LENGTHS INTO THE EXTERNAL ILIAC ARTERY. THE TREATMENT WAS SUCCESSFUL AND THE PATIENT OUTCOME WAS FAVORABLE. REVIEW OF RETURNED FILMS AT IMPLANT REVEALED THAT THE LEFT INTERNAL ILIAC ARTERY WAS COILED. THE BIFURCATE WAS BROUGHT UP THE RIGHT SIDE, AND DEPLOYED JUST BELOW THE RENAL ARTERIES. AN ILIAC EXTENSION WAS THEN IMPLANTED INTO THE RIGHT COMMON ILIAC ARTERY. THE CONTRALATERAL LIMB WAS THEN IMPLANTED INTO THE LEFT EXTERNAL ILIAC ARTERY. AFTER BALLOONING THE AORTIC BODY AND BOTH LIMBS, ANGIO SHOWED GOOD FLOW INTO THE RIGHT ILIAC ARTERY, BUT SLOW AND REDUCED FLOW INTO THE LEFT ILIAC ARTERY (RELATIVE TO THE RIGHT). THE MINIMUM LEFT LIMB OD WAS APPROXIMATELY 9MM. THE MINIMUM EXTERNAL ILIAC FLOW LUMEN DISTAL DIAMETER DISTAL TO THE STENT GRAFT WAS APPROXIMATELY 6MM. NO STENT GRAFT COMPRESSION/KINKS WERE SEEN. FINAL ANGIO SHOWED GOOD FLOW INTO THE LEFT ILIAC ARTERY; SIMILAR TO THE FLOW IN THE RIGHT ILIAC ARTERY. FILMS 1 WEEK POST-IMPLANT REVEALED THAT THE LEFT CONTRALATERAL LIMB WAS COMPLETELY OCCLUDED BEGINNING AT THE BIFURCATE FLOW DIVIDER. NO KINKS WERE SEEN. BALLOONING AS PERFORMED WITHIN THE ORIGIN OF THE LEFT COMMON ILIAC ARTERY; MINIMUM BALLOON DIAMETER WAS APPROXIMATELY 16MM IN THIS LOCATION. AFTER BALLOONING AND THROMBECTOMY, THE FLOW IMPROVED IN THE LEFT LIMB; HOWEVER, SOME THROMBUS WAS STILL VISIBLE. AFTER IMPLANTING SEVERAL STENTS, A POSSIBLE TYPE III FABRIC ENDOLEAK WAS THEN SEEN IN THE CONTRALATERAL LIMB; LIKELY PROCEDURE RELATED FROM ANOTHER DEVICE/WIRE. THE ENDOLEAK WAS RELINED WITH ANOTHER MANUFACTURER¿S DEVICE. FINAL ANGIO SHOWED NEARLY COMPLETE FLOW THROUGHOUT THE LEFT LIMB. THE MINIMAL FLOW LUMEN DIAMETER NEAR THE ORIGIN OF THE LEFT ILIAC ARTERY MEASURED 11MM, AND THE FLOW LUMEN DIAMETER OF THE LEFT EXTERNAL ILIAC ARTERY JUST DISTAL TO THE STENT GRAFT MEASURED 7MM. THE CAUSE IS UNKNOWN; MAY BE PATIENT RELATED DUE TO POOR DISTAL RUNOFF POSSIBLY CAUSED BY THE SMALL VESSELS IN THE EXTERNAL ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431454 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04146733

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention