BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2823330 · Received November 7, 2012

    Report

    Report Number
    2953200-2012-02149
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, AORTIC NECK AND ILIAC LIMB DILATATION). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, AORTIC NECK AND ILIAC LIMB DILATATION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 28 MM IN DIAMETER AND ITS LENGTH IS UNKNOWN. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP THERE WAS A DISTAL TYPE I ENDOLEAK SEEN ON THE CONTRALATERAL SIDE (RIGHT) AND THERE WAS LOSS OF SEAL RIGHT AT THE END OF THE STENT GRAFT DUE TO DILATATION OF THE LEFT ILIAC ARTERY. CURRENTLY THE LEFT ILIAC ARTERY MEASURES 18 MM IN DIAMETER AND THE ANEURYSM HAS EXPANDED TO 8.6 CM IN DIAMETER. IT WAS ALSO REPORTED THAT THE BIFURCATED STENT GRAFT HAS MIGRATED DISTALLY 1 CM; HOWEVER, THERE IS STILL A SEAL AND THERE IS NO PROXIMAL TYPE I ENDOLEAK. THE AORTIC NECK DIAMETER CURRENTLY MEASURES 31 MM IN DIAMETER AND IT IS 1.5 - 2 CM IN LENGTH. THE PHYSICIAN DECIDED TO IMPLANT A 36 ENDURANT AORTIC CUFF THE STENT GRAFT MIGRATION WAS RESOLVED AND AN ENDURANT ILIAC EXTENSION AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    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 00083 YR Required Intervention