BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFTY SYSTEM - HYDRO

    MDR report key: 1581534 · Received January 13, 2010

    Report

    Report Number
    2953200-2010-00038
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 16, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED INTERVENTION. ENDOLEAK, INACCURATE STENT GRAFT DELIVERY.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 7.8 CM ABDOMINAL AORTIC ANEURYSM. VESSELS WERE MILDLY TORTUOUS AND MILDLY CALCIFIED. THE AORTIC NECK ANGULATION WAS LESS THEN 5 DEGREES, 10 MM IN LENGTH, AND WAS 27 MM IN DIAMETER AT THE RENAL ARTERIES AND 29 MM IN DIAMETER 10 MM BELOW THE RENAL ARTERY. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN AND HAD BACK PAIN FOR THREE DAYS PRIOR TO THE INTERVENTION. THE CT SHOWED A 7.8 CM ABDOMINAL ANEURYSM AND A 4.2 CM LEFT ILIAC ANEURYSM. AS THE BIFURCATED STENT GRAFT WAS BEING DEPLOYED, THE PHYSICIAN INADVERTENTLY PULLED THE STENT GRAFT DELIVERY CATHETER DOWN SLIGHTLY FURTHER THAN INTENDED, RESULTING IN A TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO PLACE A TALENT AORTIC CUFF AT THE RENAL ARTERY, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. 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 GRAFTY SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00145082N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention