BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 2163456 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01186
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: SURGICAL CONVERSION TO OPEN REPAIR. PERSISTENT TYPE II ENDOLEAK. EVALUATION, CONCLUSIONS: PERSISTENT TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 68 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT OF THE EVENT WERE NOT REPORTED. IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AGO, THE PHYSICIAN ELECTED TO SURGICALLY-CONVERT THE PATIENT TO AN OPEN REPAIR AND EXPLANTED THE STENT GRAFTS DUE TO A PERSISTENT TYPE II ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE. THE EXPLANTED GRAFTS HAVE BEEN RECEIVED BY MEDTRONIC, AND THEIR EVALUATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 668223

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention