BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1920003 · Received December 3, 2010

    Report

    Report Number
    2953200-2010-02374
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ENDOLEAK. VESSEL TORTUOSITY AND DISEASE PROGRESSION. EVAL, CONCLUSION: VESSEL TORTUOSITY AND DISEASE PROGRESSION.

    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 37 MONTHS AGO. ANEURYSM MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP APPROXIMATELY 1 MONTH AGO, A TYPE 3 SEPARATION ENDOLEAK BETWEEN TWO OF THE DISTAL CUFFS (MFR# 2953200-2010-02375) WAS NOTED AND THE ENDOLEAK WAS ATTRIBUTED TO VESSEL TORTUOUSITY AND DISEASE PROGRESSION. CURRENTLY, THE NECK DIAMETER RANGED FROM 28 - 30 MM. AN INTERVENTION WAS PERFORMED ON (B)(6) 2010. FIRST, THE LEFT INTERNAL ILIAC ARTERY WAS ATTEMPTED TO BE EMBOLIZED; HOWEVER, THIS WAS UNSUCCESSFUL. AN ATTEMPT WAS MADE TO GO THROUGH FROM THE LEFT ARM TO PLACE THE PIGTAIL CATHETER. A 16 X 115 MM ANEURX LIMB AND AN 18 X 135 MM ANEURX LIMB WERE PLACED PROXIMALLY VIA THE LEFT SIDE TO BRIDGE THE SEPARATION. ALTHOUGH NO PROXIMAL ENDOLEAK WAS NOTED, A 28 MM ANEURX CUFF AND A 32 MM TALENT CUFF WERE PLACED PROXIMALLY, AS THE ANEURX BIFURCATED STENT GRAFT WAS NOTED TO BE 2 MM BELOW THE RENALS; HOWEVER, NO MIGRATION CAN BE CONFIRMED, AS INITIAL PLACEMENT IS UNK (SEE MFR# 2953200-2010-02376). THE PROXIMAL CUFFS WERE ADDED AS A PREVENTIVE MEASURE ONLY, NOT DUE TO AN ENDOLEAK. 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 NA V00046815

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention