BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2895650 · Received January 3, 2013

    Report

    Report Number
    2953200-2013-00014
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    October 23, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NON-CONTRAST STUDY FROM APPROXIMATELY TWO YEARS POST IMPLANT, SHOWS THE ANEURYSM HAS GROWN MODESTLY SINCE THE PREVIOUS STUDY FROM SIX MONTHS PRIOR. THERE IS NO PURCHASE ON THE RIGHT, MINIMAL IF ANY ON THE LEFT SIDE. ALSO THE PROXIMAL PURCHASE IS LESS ON THE MOST RECENT STUDY THREE MONTHS AGO VS THE STUDY FROM SIX MONTHS AGO. APPROXIMATELY ONE MONTH AGO THE RIGHT LIMB WAS EXTENDED WITH AN ENDURANT ETLW1613199E AND THE RIGHT WAS WITH AN ETEW2828C82E BOTH INTO THE EXTERNAL ILIAC ARTERIES, A PROXIMAL ENDURANT CUFF ETCF3636C49E WAS IMPLANTED PROXIMALLY AND THE ENDOLEAKS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. REFERENCE MFR # 2953200-2012-01312.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3126 TALENT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00388717

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention