BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1843498 · Received September 22, 2010

    Report

    Report Number
    2953200-2010-01805
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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). RESULTS, CONCLUSIONS: UNK CAUSE OF CANNULATION DIFFICULTY.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF A 6.5 CM ABDOMINAL AORTIC ANEURYSM APPROX 1 MONTH AGO. THE AORTIC NECK WAS UNREMARKABLE. IT WAS REPORTED THAT THE CONTRALATERAL GATE COULD NOT BE CANNULATED FOR OVER 2 HRS. IT WAS NOTED THAT THE X-RAY EQUIPMENT WENT DOWN 3 TIMES DURING THE PROCEDURE. THE DECISION WAS MADE TO CONVERT TO AN AORTO-UNI-ILIAC YS USING A TALENT CONVERTER FOLLOWED BY A FEM-FEM. NO ADDITIONAL CLINICAL 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 GALWAY NA V00457322

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention