BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM (CT)

    MDR report key: 2032437 · Received March 25, 2011

    Report

    Report Number
    2953200-2011-00698
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (STENT GRAFT WAS INITIALLY PLACED LOW INTENTIONALLY DUE TO THE ACCESSORY RENAL ARTERY), (ACCESSORY RENAL). CONCLUSIONS: (ACCESSORY RENAL), (STENT GRAFT WAS INITIALLY PLACED LOW INTENTIONALLY DUE TO THE ACCESSORY RENAL ARTERY).

    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 APPROXIMATELY 33 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT DURING A RECENT FOLLOW-UP APPROXIMATELY 1 MONTH AGO THE PROXIMAL PORTION OF THE BIFURCATED STENT GRAFT FABRIC WAS FOUND 15 MM BELOW THE RENAL ARTERIES AND THE SUPRA RENAL STENT APEXES WERE RIGHT AT THE LEVEL OF THE RENALS. THE PHYSICIAN DOES NOT BELIEVE THE STENT GRAFT MIGRATED AND THAT THIS IS WHERE THE STENT GRAFT WAS IMPLANTED. THERE WAS NO PROXIMAL TYPE 1 ENDOLEAK. THERE WAS HOWEVER, A DISTAL TYPE 1 ENDOLEAK THAT WAS COMING FROM THE LEFT (CONTRALATERAL) SIDE AND THIS WAS ATTRIBUTED TO A DILATED LEFT ILIAC ARTERY; THE DIAMETER OF THE ILIAC ARTERY IS UNKNOWN AND ITS LENGTH IS 2 CM LONG. IT WAS NOTED THAT THIS STENT GRAFT WAS NOT EXTENDED DOWN FAR ENOUGH TO THE LEVEL OF THE HYPOGASTRIC ARTERY AND CREATED A DISTAL TYPE 1 ENDOLEAK. THIS RESULTED IN ANEURYSM ENLARGEMENT (THE EXACT SIZE UNKNOWN), SEE MFR # 2953200-2011-00699. ON (B)(6) 2011, THE INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND TWO DAYS LATER ENDURANT LIMBS WERE PLACED TO EXTEND DOWN TO THE HYPOGASTRIC ON THE CONTRALATERAL SIDE. AN ENDURANT CUFF WAS PLACED PROXIMALLY TO EXTEND TO THE RENAL ARTERIES. THERE IS A BRANCH OFF THE SMA THAT APPEARS TO BE AN ACCESSORY RENAL, SO THE GRAFT WAS PLACED INTENTIONALLY LOW AT THE TIME OF IMPLANT TO PRESERVE WHAT WAS THOUGHT TO BE AN ACCESSORY RENAL. 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 (CT) MIH MEDTRONIC CARDIOVASCULAR NA V00114811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention