BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 1000424 · Received February 21, 2008

    Report

    Report Number
    2953200-2008-00070
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION). PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ENDOLEAK MAY HAVE BEEN PRESENT AT IMPLANT). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (ENDOLEAK MAY HAVE BEEN PRESENT AT IMPLANT). REQUIRED SECONDARY INTERVENTION.

    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. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH ABDOMINAL PAIN. AN ANGIOGRAM WAS PERFORMED AND REVEALED A PROXIMAL TYPE 1 ENDOLEAK AND THAT THE BIFURCATED DEVICE MAY HAVE MIGRATED 3CM. THE PT WAS FROM A DIFFERENT STATE, AND IT IS UNK WHETHER THERE WERE REGULAR FOLLOW-UP VISITS OVER THE PAST 3.5 YRS SINCE IMPLANT. IT WAS ALSO REPORTED THE AORTIC NECK WAS 24-25MM IN DIAMETER AND THAT THE TYPE 1 ENDOLEAK MIGHT HAVE BEEN PRESENT AT THE ORIGINAL IMPLANT. ANOTHER MANUFACTURER'S AORTIC CUFF WAS IMPLANTED PROXIMALLY AND RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA M03H551286

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention