BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2770976 · Received October 3, 2012

    Report

    Report Number
    2953200-2012-01906
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    PP070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION, ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DISEASE PROGRESSION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP VISIT THE STENT GRAFT WAS FOUND TO HAVE MIGRATED WITH A PROXIMAL TYPE I ENDOLEAK PRESENT. THE STENT GRAFT WAS 1.5 CM FROM THE LEVEL OF THE RENAL ARTERIES. CURRENTLY THE NECK MEASURED 31 MM IN DIAMETER. THE STENT GRAFT MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION. A 36X36X49 ENDURANT AORTIC CUFF WAS IMPLANTED AND SUCCESSFULLY RESOLVED THE ENDOLEAK. THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW UP. A RECENT CT (ON AN UNKNOWN DATE) REVEALED THAT THERE WAS A FABRIC TYPE III ENDOLEAK, FABRIC IN THE DISTAL AREA OF THE IPSILATERAL LIMB APPROXIMATELY THREE RINGS PROXIMAL TO THE BOTTOM OF THE STENT GRAFT. THE CAUSE OF THE TYPE III ENDOLEAK IS UNKNOWN. FILMS ARE NOT AVAILABLE. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY COIL EMBOLIZATION OF THE HYPOGASTRIC ARTERY AND IMPLANTATION OF TWO ENDURANT ILIAC LIMBS, A 131382 AND A 1613124 AND THE TYPE III ENDOLEAK RESOLVED. NO 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 IRELAND V00388764

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention