BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFTY SYSTEM - HYDRO

    MDR report key: 1575581 · Received December 17, 2009

    Report

    Report Number
    2953200-2009-01846
    Event Type
    Malfunction
    Date Received
    December 17, 2009
    Date of Event
    December 9, 2009
    Report Date
    December 9, 2009
    Manufacturer
    MEDTRONIC CARDIO VASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: SEVERELY TORTUOUS AND CALCIFIED VESSELS. (DELIVERY SYSTEM CATHETER). OTHER LACK OF INFO (DELIVERY SYSTEM WAS DISCARDED - UNABLE TO FOLLOW-UP). CONCLUSION: SEVERELY TORTUOUS AND CALCIFIED VESSELS.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 69 MONTHS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. THE VESSELS WERE SEVERELY TORTUOUS AND SLIGHTLY CALCIFIED. IT WAS REPORTED THAT THE PT DEVELOPED AN ILIAC ANEURYSM AND THERE WAS AN INADEQUATE SEAL BECAUSE OF THAT. HOWEVER, THERE WAS NO APPARENT ENDOLEAK INTO THE ANEURYSM SAC, AND IT WAS DETERMINED THAT THERE WAS LIKELY ENDOTENSION THROUGH THROMBUS WITHOUT AN ENDOLEAK (MFR #2953200-2009-01845). THE DECISION WAS MADE TO TREAT THE PT AT A LATER DATE. THE PT WAS BROUGHT BACK AND HAD A REVASCULARIZATION PROCEDURE OF THE LEFT HYPOGASTRIC ARTERY WITH EXTENSION OF THE ILIAC LIMB INTO THE LEFT EXTERNAL ILIAC ARTERY WITH AN ANEURX CUFF AND ANOTHER MANUFACTURER'S STENT TO EXCLUDE THE ILIAC ANEURYSM. DURING THE RE-INTERVENTION, IT WAS NOTED THAT THE AORTIC NECK HAD DISEASE PROGRESSION RESULTING IN ELONGATION ON ONE SIDE; THEREFORE, THE ANEURX STENT GRAFT WAS NO LONGER AT THE RENAL ARTERY THAT SIDE. AN ATTEMPT WAS MADE TO PLACE AN AORTIC CUFF; HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO DIFFERENT AORTIC CUFFS FOR PLACEMENT PROXIMAL TO THE BIFURCATED STENT GRAFT. THE DELIVERY CATHETERS KINKED DURING THE ADVANCEMENT DUE TO THE VESSEL MORPHOLOGY (SEE MFR #2953200-2009-01847). THE DELIVERY SYSTEM CATHETERS WERE REMOVED FROM THE PT AND DISCARDED. THE PROCEDURE WAS ENDED WITHOUT FURTHER INTERVENTION. 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 GRAFTY SYSTEM - HYDRO MIH MEDTRONIC CARDIO VASCULAR GALWAY NA V00338445

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK