BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1843523 · Received September 22, 2010

    Report

    Report Number
    2953200-2010-01796
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). RESULTS, CONCLUSIONS: (TORTUOUS AND MODERATELY CALCIFIED VESSELS).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE TORTUOUS AND MODERATELY CALCIFIED. THE RIGHT SIDE WAS LESS TORTUOUS THAN THE LEFT SIDE. IT WAS REPORTED THAT AFTER DODDERING THE VESSELS, THE DELIVERY SYSTEM OF THE TALENT BIFURCATED STENT GRAFT STILL COULD NOT BE ADVANCED TO THE ANEURYSM DUE TO THE TORTUOUS VESSEL MORPHOLOGY. THE DEVICE WAS REMOVED FROM THE PT AND A KINK WAS NOTED AT THE LOCATION OF THE STENTLESS AREA (SEE MFR # 2953200-2010-01793). THE DELIVERY SYSTEM WAS DISCARDED. ANOTHER, SMALLER TALENT BIFURCATED STENT GRAFT DEVICE WAS DELIVERED AND DEPLOYED. IT WAS EXTENDED WITH A TALENT IPSILATERAL EXTENSION. ON THE CONTRALATERAL SIDE, THE CONTRALATERAL MARKERS WERE MISTAKENLY ALIGNED WITH THE IPSILATERAL EXTENSION MARKER INSTEAD OF THE GATE MARKER. AS A RESULT, THE TALENT CONTRALATERAL LIMB WAS JUST SHORT OF THE GATE, RESULTING IN A JUNCTION TYPE 3 ENDOLEAK (SEE MFR # 2953200-2010-01794 AND MFR # 2953200-2010-01795). AN ANEURX ILIAC EXTENSION WAS USED TO BRIDGE THE GAP. UPON POST-DILATION AND ANGIOGRAM RUN, THERE WAS NO PRESENCE OF A TYPE 1 OR TYPE 3 ENDOLEAKS, AND THE PROCEDURE WAS CONCLUDED. THREE DAYS LATER, THE PT PRESENTED WITH BACK PAIN, AND A TYPE 3 LEAK AT THE GATE WAS NOTED. A TALENT LIMB WAS PLACED TO RELINE THE CONTRALATERAL GATE AREA OF THE BIFURCATED STENT GRAFT, THE CONTRALATERAL LIMB, AND THE ANEURX LIMB. A SMALL FABRIC LEAK 4.5 CM FROM THE TOP OF THE BIFURCATED STENT GRAFT ON THE CONTRALATERAL SIDE JUST ABOVE THE TALENT LIMB WAS NOTED. AN ANEURX ILIAC LIMB WAS PLACED TO COVER THE FABRIC LEAK AND POST-DILATED WITH 2 KISSING RELIANT BALLOONS. UPON THE FINAL RUN, THERE WAS NO TYPE 1 OR TYPE 3 ENDOLEAKS. NO ADDITIONAL 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 MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00507128

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention