BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM - UNK

    MDR report key: 929554 · Received October 20, 2007

    Report

    Report Number
    2953200-2007-00466
    Event Type
    Injury
    Date Received
    October 20, 2007
    Report Date
    September 24, 2007
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSION: LACK OF DETAILED INFO PROVIDED THROUGH THE ANNUAL REPORT.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY POST STENT GRAFT IMPLANTATION, THE PATIENT HAS SEEN A DIFFERENT PHYSICIAN THAN THE PHYSICIAN THAT IMPLANTED THE STENT GRAFT. IT WAS REPORTED TO MEDTRONIC VIA AN ANNUAL REPORT IDE# G990024/S15 THAT ONE PATIENT RECEIVED A TALENT PROXIMAL CUFF TO CORRECT A DISTAL MIGRATION, WITH A TYPE I ENDOLEAK. THE CAUSE OF THE MIGRATION WAS NOT REPORTED WITHIN THE ANNUAL REPORT. THE PATIENT WAS TREATED WITH A TALENT AORTIC CUFF AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM - UNK MIH MEDTRONIC VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention