BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2063839 · Received April 15, 2011

    Report

    Report Number
    2953200-2011-00824
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: GRAFT OCCLUSION. FIBROUS THROMBIN CAP. CONCLUSIONS: FIBROUS THROMBIN CAP.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THERE WAS AN OCCLUSION FROM THE FLOW DIVIDER DOWN TO THE END OF THE STENT GRAFT. THERE IS MOST LIKELY A FIBROUS THROMBIN CAP AT THE FLOW DIVIDER. THE PHYSICIAN BELIEVES THE OCCLUSION MOST LIKELY STARTED IN THE NATIVE VESSEL DISTAL TO THE IPSILATERAL ILIAC STENT GRAFT AND WORKED ITS WAY UP INTO THE STENT GRAFT (REF MFR # 2953200-2009-00963). THE PHYSICIAN ELECTED TO PLACE TWO SELF EXPANDING STENTS AT THE FLOW DIVIDER, A BALLOON EXPANDABLE STENT AT THE DISTAL END OF THE STENT GRAFT AND USED AN ANGIOJET TO REMOVE THE THROMBOSIS. IT WAS REPORTED THAT TWO YEARS POST IMPLANT THE PATIENT PRESENTED WITH LEG PAIN. IVUS WAS USED AND SHOWED THERE WAS AN OCCLUSION FROM THE FLOW DIVIDER DOWN TO THE END OF THE STENT GRAFT, BILATERALLY. THE PHYSICIAN BELIEVES THE OCCLUSION MOST LIKELY STARTED IN THE NATIVE VESSEL DISTAL TO THE IPSILATERAL LIMB AND WORKED ITS WAY UP INTO THE STENT GRAFT BILATERALLY. AN ENDARTERECTOMY WAS PERFORMED AND THE OCCLUSION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00222545

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention