BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010791 · Received March 2, 2011

    Report

    Report Number
    2953200-2011-00576
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: ENDOLEAK. SOURCE OF ENDOLEAK IS UNKNOWN. CONCLUSION: SOURCE OF ENDOLEAK IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS BEING SEVERELY TORTUOUS IN THE RIGHT ILIAC ARTERY AND MILDLY TORTUOUS IN THE LEFT ILIAC ARTERY WITH UNKNOWN CALCIFICATION BILATERALLY. THE ANEURYSM WAS 69.5 MM IN DIAMETER. THE AORTIC NECK WAS 22 MM IN LENGTH, WITH A DIAMETER OF 24.1 MM BELOW THE RENALS AND 25.6 MM AND 22 MM JUST ABOVE THE ANEURYSM. THE AORTIC NECK ANGLE WAS 39.7 DEGREES. THE AORTIC BIFURCATION IS 55.1 MM IN DIAMETER. THE RCIA IS TORTUOUS AND IT'S DIAMETER WAS 16.5. THE LCIA IS 15.1 MM AND THE STENT GRAFT WAS INSERTED FROM THE LEFT. AFTER SUCCESSFUL DEPLOYMENT OF THE STENT GRAFT IMPLANTED ON (B)(6) 2011, IT WAS REPORTED THAT AN ENDOLEAK WAS NOTED. THERE WAS A LIGHT CONTRAST BLUSH IN THE ANEURYSM SAC ON THE POST ANGIOGRAM. SEVERAL BALLOON INFLATIONS AND VIEWS WERE TAKEN IN ATTEMPT TO IDENTIFY THE SOURCE. THE PHYSICIAN SUSPECTED A TYPE 4 ENDOLEAK, BUT IT IS UNDETERMINED. THE PATIENT IS FINE AND WILL BE MONITORED AT 30 DAYS. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00512246

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention