BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2821629 · Received November 6, 2012

    Report

    Report Number
    2953200-2012-02134
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    January 1, 2011
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). (CAUSE IS UNKNOWN). CONCLUSIONS: (CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PHYSICIAN REVIEWED A CASE OF A PATIENT THAT WAS TREATED WITH A TALENT STENT GRAFT. AT THE TIME OF IMPLANT IT WAS REPORTED, ONE RENAL ARTERY APPEARED COMPROMISED WITH A POSSIBLE RENAL ANEURYSM THAT WAS NOT TREATED AT THAT TIME. THE IMPLANT PROCEDURE WAS CONSIDERED SUCCESSFUL AT THE TIME AND THE POSITIONING OF THE DEVICE WAS DESCRIBED AS ACCURATE. AT THE PATIENT'S 6 MONTH FOLLOW UP THE OTHER RENAL ARTERY HAD DEVELOPED STENOSIS AND REQUIRED TREATMENT. A STENT WAS USED TO OPEN UP THE VESSEL AND THE PATIENT RECOVERED WELL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. EXACT DATE OF IMPLANT AND EXACT DATE OF IMPLANTATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention