BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1192569 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00905
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ARTERIAL AND VENOUS OCCLUSION. LARGE 'S' SHAPED AORTIC NECK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 30 MM IN DIAMETER AND IT HAD AN ANGULATION OF 25 - 30 DEGREES. ONE CENTIMETER DISTALLY THE AORTIC NECK HAD A REVERSE ANGLE MAKING IT 'S' SHAPED. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS DEPLOYED AN APEX OF ONE OF THE INFRA-RENAL STENTS LANDED INSIDE THE OSTIUM OF ONE OF THE RENAL ARTERIES. THE PHYSICIAN COMMENTED THIS WAS AN ANATOMICAL ISSUE. ON CT SCAN THE RENAL ARTERIES APPEARED AS THEY WERE DIRECTLY OPPOSITE OF EACH OTHER. AN ATTEMPT WAS MADE TO MANUALLY PULL THE BIFURCATED STENT GRAFT DOWN USING THE DELIVERY SYSTEM WHILE THE IPSILATERAL LIMB WAS STILL WITHIN THE GRAFT COVER; HOWEVER, THAT CAUSED MORE OF THE STENT GRAFT TO DEPLOY. THE PHYSICIAN FELT IT WAS BETTER TO NOT INTERVENE ANY FURTHER. ADDITIONAL REVIEW OF THE FILMS FROM THE CASE SHOWED THAT FLOW TO THE RENAL ARTERY DOES NOT APPEAR COMPROMISED; HOWEVER, WITHOUT ULTRASOUND OF A MAGNIFIED VIEW IT WAS DIFFICULT TO ASSES THE PERCENTAGE OF THE OCCLUSION. 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 V00167508

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention