BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM -HYDRO

    MDR report key: 1900462 · Received October 28, 2010

    Report

    Report Number
    2953200-2010-02083
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ARTERIAL/VESSEL OCCLUSION), (REVERSE CONE SHAPED AORTIC NECK; SEVERELY TORTUOUS VESSELS). EVAL, CONCLUSION: (REVERSE CONE SHAPED AORTIC NECK; SEVERELY TORTUOUS VESSELS), (PLACING STENT GRAFT HIGHER THAN INTENDED).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 3.5 CM ABDOMINAL AORTIC ANEURYSM AND A 3.5 CM ILIAC ANEURYSM. THE AORTIC NECK WAS REVERSE CONE SHAPED, 21 MM DIAMETER AT THE RENAL ARTERIES AND 24 MM IN DIAMETER 2.5 MM DISTALLY. THE ILIAC VESSELS WERE SEVERELY TORTUOUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT THE TALENT BIFURCATED STENT GRAFT (MFR REPORT # 2953200-2010-02082) WAS INADVERTENTLY PULLED DOWN DURING THE REMOVAL OF ITS DELIVERY CATHETER, RESULTING IN A PROXIMAL TYPE I ENDOLEAK AND KINKING OF THE IPSILATERAL LIMB. THE PHYSICIAN STATED THE DELIVERY SYSTEM HAD BECOME CAUGHT ON THE SEVERELY TORTUOUS VESSEL. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING AN ANEURX AORTIC CUFF; HOWEVER, THE CUFF WAS PLACED HIGHER THEN INTENDED, PARTIALLY COVERING THE RENAL ARTERY. THE PHYSICIAN ELECTED TO PLACE A BARE METAL RENAL STENT, WHICH MADE THE RENAL ARTERY PATENT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM -HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00348815

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention