BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CONVERTER

    MDR report key: 2161873 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01263
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK), (USE OF THE DEVICE IN A NECK LARGER THAN 32 MM). EVALUATION, CONCLUSION: (USE OF THE DEVICE IN A NECK LARGER THAN 32 MM).

    Description of Event or Problem · 1

    AN ANEURX (REF. MFR. 2953200-2011-01262) ABDOMINAL STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 43 MONTHS AGO. VESSEL MORPHOLOGY FROM THE INDEX PROCEDURE IS UNK. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS WAS SOME ANGULATION IN THE NECK, WHICH WAS DILATED TO A 34 MM DIAMETER AT THE RENALS, WITH A 2 CM LENGTH; AND NO CALCIFICATION IN THE NECK. IT WAS REPORTED THAT ONE MONTH AGO, THE ORIGINAL STENT GRAFT HAD MIGRATED 4 CM AND THERE WAS A TYPE 1 ENDOLEAK, PROBABLY DUE TO DISEASE PROGRESSION AND NECK DILATATION. THE PHYSICIAN PLACED A 36X16X124 TALENT CONVERTER (REF. MFR. 2953200-2011-01263) INTO THE RIGHT ANEURX LIMB, AND EXTENDED WITH A 16X65 ANEURX LIMB. AN 18 MM TALENT OCCLUDER WAS PLACED ON THE LEFT. TWELVE DAYS LATER, THERE APPEARED TO BE A QUESTIONABLE LEAK AT THE PROXIMAL ASPECT OF THE CONVERTER ON A FOLLOW-UP CT. A PALMAZ STENT WAS PLACED DUE TO A PLEAT IN THE GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00847049

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention