BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2130015 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01113
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (DISEASE PROGRESSION WITH AORTIC NECK DILATATION), (USE OF THORACIC DEVICE IN THE ABDOMINAL AORTA). EVAL, CONCLUSION: (DISEASE PROGRESSION WITH AORTIC NECK DILATATION), (USE OF THORACIC DEVICE IN THE ABDOMINAL AORTA).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 24 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. A TALENT ABDOMINAL STENT GRAFT (REF MFR # 2953200-2011-01111), TWO ANEURX ILIAC LIMBS (REF MFR # 2953200-2011-01112), ONE ANEURX ILIAC EXTENSION, AND ONE TALENT THORACIC STENT GRAFT (REF MFR # 2953200-2011-01113). IT WAS REPORTED THAT THE PT HAD A PROXIMAL AND A DISTAL TYPE I ENDOLEAKS APPROX 10 MONTHS POST STENT GRAFT IMPLANT DUE TO DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND WAS TREATED WITH TWO TALENT THORACIC CUFFS FOR THE PROXIMAL TYPE I ENDOLEAK AND AN ANEURX EXTENSION WAS PLACED FOR THE DISTAL TYPE I ENDOLEAK. RECENTLY THE CT DEMONSTRATED THAT THERE IS A TYPE I ENDOLEAK OF THE PROXIMAL THORACIC CUFF (REF MFR # 2953200-2011-01114). AN ANGIOGRAM IS PLANNED TO DETERMINE THE COURSE OF INTERVENTION IF ANY INTERVENTION WILL BE REQUIRED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00202491

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention