BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 2102884 · Received May 4, 2011

    Report

    Report Number
    2953200-2011-00924
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DEVICE MALFUNCTION, STENT GRAFT MISPLACEMENT); LACK OF INFO (ANEURYSM AND VESSEL MORPHOLOGY ARE UNK, UNK CAUSE OF REMOVAL DIFFICULTY). CONCLUSION: LACK OF INFO (ANEURYSM AND VESSEL MORPHOLOGY ARE UNK, UNK CAUSE OF REMOVAL DIFFICULTY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL AND ANEURYSM MORPHOLOGY WERE NOT REPORTED. THE DELIVERY CATHETER WAS DISCARDED BY THE USER FACILITY. THE STENT GRAFT WAS FULLY DEPLOYED; HOWEVER, UPON REMOVAL OF THE DELIVERY CATHETER, THE SPINDLE/NOSECONE WAS CAUGHT IN THE APEX/BARE METAL OF THE STENT GRAFT AND THE APEX WAS PULLED INTO DOWN, INVERTED INTO THE STENT GRAFT SYSTEM. THEN PHYSICIAN IMMEDIATELY RE-OPENED THE SPINDLE, RE-ADVANCED THE DELIVERY SYSTEM, RE-CLOSED THE SPINDLE AGAIN AND WAS ABLE TO REMOVE THE DELIVERY CATHETER FROM THE PT. HOWEVER, ONE OF THE APEX/BARE METAL STENTS HAS REMAINED INVERTED/BENT INSIDE THE LUMEN OF THE STENT GRAFT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. THE IMAGES HAVE BEEN REVIEWED AND THERE ARE NO OBVIOUS SIGNS OF A STENT FRACTURE AND THE STENT ITSELF APPEARS TO BE SITTING CLOSER TO THE VESSEL WALL. FROM THE FLY-THROUGH INNER LUMEN IMAGE GENERATED, THE LUMEN APPEARS PATENT AND UN-OBSTRUCTED BY THE EFFECTED STENT. AS AN EFFECTIVE SEAL WAS OBTAINED AT THE TIME OF THE PRIMARY PROCEDURE, THERE IS NO NEED AT THIS STAGE FOR SECONDARY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT MIH MEDTRONIC IRELAND NA V00805800

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR