BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1870994 · Received October 8, 2010

    Report

    Report Number
    2953200-2010-01919
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: TREATMENT OF PRE-EXISTING RUPTURED ABDOMINAL AORTIC ANEURYSM, THE AORTIC NECK WAS SHORT IN LENGTH (9MM), SEVERELY ANGULATED AND HAD A REVERSE FUNNEL, 21MM PROXIMALLY TO DISTALLY 24MM IN DIAMETER. ENDOLEAK. THE EXPLANTED STENT WAS DISCARDED, UNABLE TO F/U. EVAL, CONCLUSIONS: TREATMENT OF PRE-EXISTING RUPTURED ABDOMINAL AORTIC ANEURYSM, THE AORTIC NECK WAS SHORT IN LENGTH (9MM), SEVERELY ANGULATED AND HAD A REVERSE FUNNEL, 21MM PROXIMALLY TO DISTALLY 24MM IN DIAMETER.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN A PT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM 1 MONTH AGO. ANEURYSM SIZE WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS SHORT IN LENGTH (9MM), SEVERELY ANGULATED AND HAD A REVERSE FUNNEL, 21MM PROXIMALLY TO DISTALLY 24MM IN DIAMETER. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED, THE FINAL ANGIOGRAM SHOWED NO ENDOLEAKS. IT WAS REPORTED THAT LATER THAT SAME DAY THE PT WAS BROUGHT BACK TO THE OPERATING ROOM AND THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO CONVERT THE PT TO AN OPEN SURGICAL REPAIR, DUE TO THE SHORT LENGTH AND SEVERE ANGULATION OF THE AORTIC NECK. THE EXPLANTED STENT GRAFTS WERE DISCARDED BY THE USER FACILITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00426783

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention