BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CONVERTER STENT GRAFT

    MDR report key: 2100704 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01004
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (PREVIOUSLY IMPLANTED ILIAC STENT), (GRAFT KINKING, SURGICAL CONVERSION TO OPEN REPAIR). EVAL SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS EVAL IS COMPLETE. THERE WERE NO STENT GRAFT INTEGRITY ISSUES OBSERVED, IT APPEARS THAT THE COMPLAINT WAS DUE TO THE PREVIOUSLY IMPLANTED ILIAC STENT.

    Description of Event or Problem · 1

    A TALENT CONVERTER STENT GRAFT WAS IMPLANTED INSERTED A PT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PT HAD BEEN ADMITTED FOR SOMETHING ELSE. THE RIGHT ILIAC WAS OCCLUDED DUE TO A COMPLETELY THROMBOSED RIGHT ILIAC ANEURYSM. THE LEFT ILIAC WAS UNREMARKABLE WITHOUT CALCIFICATION AND TORTUOSITY AND LARGE IN DIAMETER BUT CONTAINED AN ILIAC STENT. AN ILIAC STENT HAD BEEN PLACED IN THE LEFT ILIAC FOUR MONTHS AGO UNNECESSARILY FOR NO APPARENT REASON. THE ILIAC STENT WAS UNDERSIZED AND ALREADY LOOSE, WITH PART OF THE STENT APPOSED TO THE ILIAC WALL AND PART INSIDE THE AAA. PRIOR TO THE EVAR CASE WITH A TALENT CONVERTER, IT WAS ANTICIPATED THAT THE ILIAC STENT MIGHT COMPLICATE THE PROCEDURE AND THAT AN OPEN REPAIR MIGHT BE NECESSARY. AT THE CASE, A 12 MM BALLOON WAS USED TO DILATE THE LEFT ILIAC. THE TALENT CONVERTER WAS DEPLOYED WITHOUT ISSUES, BUT THE ILIAC STENT CAUGHT ON THE STENT GRAFT AND STARTED TO COMPRESS THE STENT GRAFT. IT WAS THEN DECIDED TO CONVERT THE PT, AND THE ILIAC STENT WAS REMOVED AT THE CONVERSION. THE DELIVERY SYSTEM HAD NO KINKING EVIDENT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER STENT GRAFT MIH MEDTRONIC IRELAND NA V00476417

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention