BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1061435 · Received June 17, 2008

    Report

    Report Number
    2953200-2008-00425
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANGULATED ANEURYSM, FREE FLOATING CALCIFIED MATERIAL IN THE ANEURYSM SAC). CONCLUSION: DEVICE FAILURE LACK OF EFFECTIVENESS RELATED TO PT CONDITION (ANGULATED ANEURYSM, FREE FLOATING CALCIFIED MATERIAL IN THE ANEURYSM SAC).

    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. THE ANEURYSM HAD UNUSUAL ANGULATION AND WHEN THE CONTRALATERAL GATE OPENED, IT WAS 2 CM ABOVE THE BIFURCATION AND IT WAS IN THE LATERAL ANTERIOR POSITION WHICH WAS VISUALIZED BY MOVING THE C-ARM TO 90 DEGREES. THE PHYSICIAN CONSIDERED CONVERTING THE DEVICE TO AORTO-UNI-ILIAC SYSTEM; HOWEVER, THE REQUIRED EQUIPMENT AND STENT GRAFT NEEDED FOR THE CONVERSION WERE NOT AVAILABLE. THE PHYSICIAN ELECTED TO PERFORM AN OPEN SURGICAL CONVERSION AFTER WHICH A DACRON GRAFT WAS SEWN IN. IT WAS ALSO REPORTED THAT WHEN THE ANEURYSM WAS OPENED, THERE WAS CALCIFIED MATERIAL VISUALIZED THAT WAS FLOATING FREELY IN THE ANEURYSM SAC AND THAT IS THE REASON THE CONTRALATERAL GATE WAS BLOCKED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT WAS FINE THE NEXT DAY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00076404

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention