BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT

    MDR report key: 2191179 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01356
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P07007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (THROMBOSIS). RESULTS AND CONCLUSION: (THE LENGTH TO THE INTERNAL ILIAC ARTERY WAS SHORT, SO THE CONTRALATERAL LIMB WAS PUSHED HIGHER THAN NORMAL).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 41MM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE RCIA WAS 32 MM IN LENGTH AND THE LCIA WAS 48 MM IN LENGTH. THE TALENT BIFURCATED STENT GRAFT WAS ON THE RIGHT SIDE AND THE CONTRALATERAL LIMB WAS ON LEFT SIDE. IT WAS REPORTED THAT ON AN UNK DATE, STENOSIS AND THROMBOSIS WERE CONFIRMED IN THE BIFURCATED STENT GRAFT (REF MFR # 2953200-2011-01356). AN EMERGENCY OPERATION WAS PERFORMED. ASPIRATION WAS PERFORMED USING ANOTHER MFR'S CATHETER AND A STENT WAS DEPLOYED AT THE AREA OF STENOSIS. THE PHYSICIAN COMMENTED THAT THE LENGTH TO THE INTERNAL ILIAC ARTERY WAS SHORT, SO THE CONTRALATERAL LIMB WAS PUSHED HIGHER THAN NORMAL (REF FR # 2953200-2011-01357); THEREFORE, THE OPEN WEB OF THE MAY HAVE CAUSED THE STENOSIS AT THE FLOW DIVIDER IN THE BIFURCATED DEVICE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA V00808235

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention