BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2840863 · Received November 20, 2012

    Report

    Report Number
    2953200-2012-02252
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (CATHETER BREAKAGE); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY TORTUOUS ILIAC ARTERIES); FAILURE TO FOLLOW INSTRUCTIONS (REMOVING THE GUIDEWIRE DURING THE IMPLANT, LEADING TO THE D-S KINK); INCORRECT TECHNIQUE/PROCEDURE (TREATING ONLY AN ILIAC ANEURYSM - NO AAA). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY TORTUOUS ILIAC ARTERIES); DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT (TAPERED TIP); USER ERROR CONTRIBUTED TO EVENT (REMOVING THE GUIDEWIRE DURING THE IMPLANT, LEADING TO THE D-S KINK).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: (FILMS).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REVIEW OF THE RETURNED FILMS HAS BEEN COMPLETED. EIGHT (8) STILL ANGIOGRAMS IMAGES FROM THE IMPLANT WERE REVIEWED. AN ILIAC LIMB WAS OBSERVED PLACED WITHIN THE SEVERELY TORTUOUS LEFT ILIAC. THE STENT GRAFT WAS ACUTELY ANGULATED, APPROXIMATELY 90 DEGREE, BETWEEN THE 3RD AND 4TH MOST PROXIMAL STENT RINGS. THE STENT GRAFT HAD NOT BEEN PLACED WITHIN A BIFURCATED DEVICE; THE PROXIMAL END OF THE STENT GRAFT WAS WITHIN THE DISTAL PORTION OF THE AAA SAC. THE INTACT DELIVERY SYSTEM TIP IS SEEN JUST ABOVE THE PROXIMAL END OF THE STENT GRAFT. ANOTHER IMAGE SHOWS THE TIP HAS BEEN PULLED INSIDE THE STENT GRAFT, AND A FINAL IMAGE SHOWS THAT THE TIP HAD DETACHED FROM THE GUIDEWIRE; THE TIP REMAINED WEDGED WITHIN THE KINKED PROXIMAL PORTION OF THE ILIAC STENT GRAFT. FROM THESE IMAGES, IT APPEARS THAT THE HIGHLY ANGULATED ILIAC ARTERY, EXACERBATED BY THE LOSS OF WIRE SUPPORT AND LACK OF PLACEMENT WITHIN A BIFURCATE, LIKELY CONTRIBUTED TO THE TIP DETACHMENT. EVALUATION OF THE RETURNED DEVICE WAS COMPLETED. BASED ON EVALUATION OF THE RETURNED DEVICE AND THE REPORTED CLINICAL INFORMATION, THE TIP DETACHMENT COMPLAINT IS DETERMINED TO BE RELATED TO USER ERROR DURING THE USE OF THE DEVICE AND THE PATIENT TORTUOUS ANATOMY. THE USER PERFORMED WIRE EXCHANGE DURING THE PROCEDURE AGAINST IFU INSTRUCTIONS, WHICH CAUSED THE DEVICE TO KINK AND THE SUBSEQUENT CHAIN OF EVENTS THAT LED TO THE TIP DETACHMENT.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LEFT COMMON ILIAC ARTERY ANEURYSM APROOXIMATELY THREE WEEKS AGO. THE VESSEL HAD LITTLE CALCIFICATION WITH SEVERE TORTUOSITY. IT WAS REPORTED THAT THE LARGE ANEURYSM IN THE LEFT COMMON ILIAC ARTERY REQUIRED COILING PRIOR TO STENT GRAFT PLACEMENT. THE PHYSICIAN SUCCESSFULLY COILED THE INTERNAL ILIAC ARTERY EXCLUDING THE ANEURYSM. THE ILIAC STENT GRAFT WAS INSERTED IN THE PATIENT OVER AN AMPLATZ SUPER STIFF WIRE; HOWEVER, DUE TO THE SEVERE TORTUOSITY, THE PHYSICIAN ELECTED TO EXCHANGE THE WIRE WITH A BACK-UP MEIER WIRE. DURING THE WIRE EXCHANGE THE ENTIRE DELIVERY CATHETER KINKED AT THE TOP. THE MEIER WIRE COULD NOT ADVANCE THROUGH THE TIP OF THE DEVICE BECAUSE THE WIRE LUMEN WAS KINKED DURING THE ADVANCEMENT OF THE DELIVERY SYSTEM OR REMOVAL OF THE AMPLATZ STIFF WIRE. DURING THE ATTEMPT TO EXCHANGE THE WIRES THE TAPER TIP WAS PUSHED PROXIMALLY/UPWARDS AGAIN AND DISCONNECTED/BROKE AWAY FROM THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM, HOWEVER THE TAPER TIP REMAINED STATIONARY IN THE DEPLOYED STENT GRAFT. THE PATIENT WAS FINE AT THIS TIME AND THE DECISION WAS MADE TO RETRIEVE THE TAPER TIP AT A LATER TIME. THE PATIENT WAS BROUGHT BACK AND THE TIP WAS REMOVED VIA THE BRACHIAL ACCESS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE TAPERED TIP WAS RECEIVED AND ITS ANALYSIS IS PENDING.

    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 V01704724

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention