BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1760599 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01311
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    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): EVALUATION RESULTS: GRAFT OCCLUSION. NARROW AORTIC BIFURCATION; ANEURYSM MAY HAVE CHANGED MORPHOLOGY. EVALUATION CONCLUSIONS: NARROW AORTIC BIFURCATION; ANEURYSM MAY HAVE CHANGED MORPHOLOGY.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 3 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED, OTHER THEN THAT THE AORTIC BIFURCATION WAS NARROW. DURING THE PROCEDURE, AN ANEURX STENT GRAFT WAS IMPLANTED AS THE CONTRALATERAL LIMB. APPROXIMATELY 2 MONTHS POST-IMPLANTATION, THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG. THE CT DEMONSTRATED THAT THERE WAS STENT GRAFT OCCLUSION DUE TO THROMBOSIS. WHICH STARTED JUST PROXIMALLY TO THE BIFURCATION OF THE TALENT BIFURCATED STENT GRAFT AND CONTINUED DOWN THROUGH THE ANEURX CONTRALATERAL LIMB (MFR REPORT # 2953200-2010-01312). THE PHYSICIAN ELECTED TO USE AN ANGIOJET CATHETER TO REMOVE MOST OF THE THROMBOSIS. HOWEVER, THERE WAS A LARGE CLOT THAT REMAINED AND COULD NOT BE REMOVED WITH THE ANGIOJET. THE PHYSICIAN ELECTED TO IMPLANT A BARE METAL STENT TO COMPRESS THE CLOT AGAINST THE VESSEL WALL. THE ANEURYSM REPORTEDLY MAY HAVE CHANGED MORPHOLOGY SINCE THE TIME OF IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention