BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1062094 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00429
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: UNABLE TO SEE THE ENDOLEAK ON THE ANGIOGRAM). SECONDARY INTERVENTION PERFORMED.

    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. IT WAS REPORTED THAT THE FINAL ANGIOGRAM DID NOT REVEAL A TYPE I ENDOLEAK, HOWEVER, THE CARDIO-MEMS SENSOR DETECTED AN ENDOLEAK. THE PHYSICIAN STATED THERE WAS NO EVIDENCE OF AN ENDOLEAK ON THE FINAL ANGIOGRAM/FILM, HOWEVER, THE PHYSICIAN ELECTED TO PLACE ANOTHER MANUFACTURER'S STENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00099019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention