BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2834335 · Received November 15, 2012

    Report

    Report Number
    2953200-2012-02212
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (INSUFFICIENT INFORMATION; CAUSE OF THE THROMBOSIS IN THE RIGHT LEG IS UNKNOWN). CONCLUSION: (INSUFFICIENT INFORMATION; CAUSE OF THE THROMBOSIS IN THE RIGHT LEG IS UNKNOWN).

    Additional Manufacturer Narrative · 1

    METHOD: FILM.

    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. THERE WAS MODERATE CALCIFICATION WITH EXCESSIVE TORTUOSITY IN THE RIGHT ILIAC ARTERY. IT WAS REPORTED THAT AN ARCHER GUIDE WIRE WAS USED INSIDE OF A 23 CM 7F SHEATH - TO STRENGTHEN THE TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. THE DISTAL 15 CM SECTION OF THE ARCHER COMPLETELY DETACHED FROM THE CORE OF THE GUIDE WIRE. BOTH PARTS OF THE ARCHER WIRE WERE SUCCESSFULLY REMOVED FROM PATIENT'S BODY. DURING THE PROCEDURE RIGHT EXTERNAL ILIAC ARTERY WAS PERFORATED. IN ORDER TO CANNULATE THE CONTRALATERAL GATE OF THE STENT GRAFT THE CROSSOVER APPROACH WAS USED AND THE TIP OF THE GUIDE WIRE WAS CAUGHT BY SNARE. AFTER THE CONTRALATERAL LEG WAS IMPLANTED AN ETLW1610C199EE WITH ITS DISTAL PART IN RIGHT EXTERNAL ILIAC ARTERY. A PTA 8 MM X 10 CM BALLOON WAS USED INSIDE DISTAL PART OF ENDURANT CONTRALATERAL LEG TO POST DILATE IT. IN THE FINAL ANGIOGRAPHY NO SIGNIFICANT ENDOLEAK WAS DETECTED AND THE PROCEDURE WAS COMPLETED. ONE HOUR AFTER THE PROCEDURE PATIENT COMPLAINED ABOUT TINGLING AND LOW TEMPERATURE OF THE RIGHT LEG. THE CAUSE OF TINGLING WAS THROMBOSIS IN THE DISTAL SFA, POPLITEAL ARTERY AND TIBIOPERONEAL TRUNK OF THE RIGHT LEG. SECONDARY INTERVENTION WAS PERFORMED, A THROMBECTOMY OF THE RIGHT LEG ARTERIES (WITH SUCCESSFUL OUTCOME). THERE WAS NO THROMBOSIS (OCCLUSION) OF THE STENT GRAFT AND IT REMAINS PATENT. THE PATIENT COMPLAINED ABOUT INTESTINE PROBLEMS (POSSIBLE INTESTINE ISCHEMIA). POSSIBILITY OF INTESTINE PERFORATION BY THE GUIDEWIRE TIP WAS INVESTIGATED (NO PERFORATION WAS DETECTED). ANGIOGRAM CT WAS DONE BEFORE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE DETAILED EXAMINATION REVEALED COEXISTING SPINE DISEASE AND TUMOR IN ABDOMEN. THE PATIENT WAS REFERRED TO INTERNAL DISEASES SPECIALIST FOR E XTRA EXAMINATION. THE PATIENT WAS DISCHARGED FROM HOSPITAL EIGHT DAYS POST INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE WIRE BROKE IN THE BENT AND CALCIFIED SECTION OF THE EXTERNAL ILIAC ARTERY, INSIDE ANOTHER MANUFACTURER'S 7F ANGIOGRAPHIC SHEATH. THE SHEATH BROKE AS WELL. THE DISTAL SECTION OF ARCHER SEPARATED FROM THE CORE AND STIFF CORE OF THE GUIDEWIRE PERFORATED THE SHEATH AND THE VESSEL (EXTERNAL ILIAC ARTERY). AFTER THIS EXTRAVASATION OF CONTRAST WAS VISIBLE. THE DECISION WAS TO COMPLETE THE PROCEDURE, CANNULATE THE CONTRALATERAL STUB AND INSERT A LONGER CONTRALATERAL LEG THAN PLANNED TO COVER THE PERFORATED VESSEL REGION. AFTER SOME MANEUVERS A 0.014" GUIDEWIRE WAS INSERTED FROM THE LEFT SIDE, CROSSED THE STENTGRAFT BIFURCATION AND ITS TIP WAS CAUGHT BY A SNARE IN THE REGION OF THE RIGHT COMMON ILIAC ARTERY ANEURYSM. THE BROKEN ARCHER AND THE SHEATH WAS REMOVED FROM THE PATIENT AND A NEW SHEATH AND A NEW ARCHER WERE USED TO IMPLANT THE CONTRALATERAL LEG. IT IS POSSIBLE THAT HIGHER FORCE WAS USED TO PUSH THE GUIDEWIRE THROUGH THE BENT SECTION OF THE VESSEL. THE WIRE DID NOT CATCH ON ANYTHING. FILMS WERE REVIEWED AS FOLLOWS: PRE-IMPLANT FILMS SHOW A 7CM THROMBUS FILLED AAA. THE AAA EXTENDED INTO THE RIGHT COMMON ILIAC ARTERY WHICH MEASURED 7CM MAXIMUM; 2CM MINIMAL FLOW LUMEN DIAMETER. DISTAL TO THE ILIAC ANEURYSM, THE RIGHT EXTERNAL ILIAC WAS EXTREMELY TORTUOUS AND CALCIFIED. FILMS AT IMPLANT SHOW THAT THE MAIN DEVICE WAS BROUGHT UP THE LEFT SIDE AND IMPLANTED. THE ARCHER WIRE WAS PLACED WITHIN THE RIGHT ILIAC ARTERY. INITIALLY, THE WIRE APPEARED KINKED, AND THE FOLLOWING IMAGE THE WIRE APPEARED BROKEN NEAR THE AREA OF THE RIGHT EXTERNAL ILIAC ARTERY. THE CAUSE OF THE BREAK WAS LIKELY ANATOMY RELATED; TORTUOUS AND CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. FINAL ANGIO SHOWED NO OBVIOUS STENT GRAFT RELATED ISSUES. POST-IMPLANT CTA SHOWED THAT THE BIFURCATE WAS PLACED JUST BELOW THE RENALS. THE DISTAL END OF THE CONTRALATERAL (RIGHT) LIMB WAS POSITIONED JUST DISTAL TO THE RIGHT ILIAC ARTERY ANEURYSM; NO OBVIOUS ENDOLEAKS WERE OBSERVED. THE AAA MEASURED 6CM MAX AND THE RCIA ANEURYSM WAS 7CM MAXIMUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01001967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention