BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM-HYDRO

    MDR report key: 1363170 · Received April 14, 2009

    Report

    Report Number
    2953200-2009-00450
    Event Type
    Injury
    Date Received
    April 14, 2009
    Date of Event
    March 23, 2009
    Report Date
    March 23, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, SECONDARY INTERVENTION. EVALUATION: RESULTS: (ENDOLEAK) AND (AORTIC NECK IS 1 CM IN LENGTH WITH 60 DEGREE ANGULATION). CONCLUSION: (AORTIC NECK IS 1 CM IN LENGTH WITH 60 DEGREE ANGULATION).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK IS 1 CM IN LENGTH WITH 60 DEGREE ANGULATION. THE NECK MEASURES 24 MM IN DIAMETER AND THE ILIAC MEASURE 13-14 MM IN DIAMETER. THE STENT GRAFT SYSTEM WAS IMPLANTED HOWEVER, UPON FINAL ANGIOGRAM THERE WAS A TYPE I ENDOLEAK. THE PHYSICIAN PLACED AN ANEURX STENT GRAFT HOWEVER, THE ENDOLEAK DID NOT RESOLVE. (MDR- 2952300-2009-00451). THE PHYSICIAN PLACED A PALMAZ STENT AND THE TYPE I ENDOLEAK RESOLVED. IT WAS REPORTED THAT DURING THE INSERTION OF EITHER THE ANEURX CUFF OR PALMAZ STENT THE ILIAC LIMB WAS REPOSITIONED PROXIMALLY ABOUT 1 CM ABOVE THE FLOW DIVIDER (MDR- 2952300-2009-00452). THE PHYSICIAN PLACED A SECOND ILIAC LIMB TO COVER THE AREA WHERE THE FIRST ILIAC LIMB HAD BEEN MOVED. THE PHYSICIAN IS UNSURE WHEN THE CONTRA ILIAC STENT GRAFT LIMB WAS PUSHED ABOVE THE FLOW DIVIDER BUT THE PHYSICIAN BELIEVES IT MAY HAVE OCCURRED WHEN CHANGING THE VARIOUS EXCHANGES TO REPAIR THE TYPE 1 LEAK. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM-HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00183185

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention