BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 3132748 · Received May 29, 2013

    Report

    Report Number
    2953200-2013-01015
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: KINK. DISEASE PROGRESSION. TREATMENT OF A CONTAINED RUPTURED ABDOMINAL AORTIC ANEURYSM. CONCLUSION: DISEASE PROGRESSION. TREATMENT OF A CONTAINED RUPTURED ABDOMINAL AORTIC ANEURYSM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A LARGE CONTAINED RUPTURED ABDOMINAL AORTIC ANEURYSM. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS SEVERE TORTUOSITY IN THE ILIAC ARTERIES, THERE WAS AN 80 DEGREE ANGULATION IN THE AORTIC NECK, ELONGATION OF THE AORTIC NECK AND CONTINUED DISEASE PROGRESSION. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED A KINK IN THE UNSUPPORTED STENT AREA OF THE TALENT BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO IMPLANT PALMAZ BARE METAL STENT IN THE UNSUPPORTED STENT AREA. THE PHYSICIAN ELECTED TO EXTEND THE IPSILATERAL LIMB PROPHYLACTICALLY, THERE WERE NO ISSUES. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS STABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THERE IS STENT GRAFT MIGRATION DUE TO DISEASE PROGRESSION AND AORTIC NECK DILATATION. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235024 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00494325

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention