BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1162829 · Received September 16, 2008

    Report

    Report Number
    2953200-2008-00813
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MIGRATION, ENDOLEAK. DEVICE NOT RETURNED DUE TO SHIPPING COMPANY LOSING THE PACKAGE. CONCLUSION: AORTIC NECK DILATATION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. ANEURYSM SIZE AT THE TIME OF IMPLANT IS UNKNOWN. THE PATIENT DID NOT RETURN FOR FOLLOW UP APPOINTMENTS AFTER STENT GRAFT IMPLANT. IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS POST STENT GRAFT IMPLANT, THE STENT GRAFT WAS EXPLANTED FROM THE PATIENT. THE CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED RESULTING IN A TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO SURGICALLY CONVERT THE PATIENT TO A CONVENTIONAL STENT. THE STENT GRAFT WAS SHIPPED, HOWEVER THE SHIPPING COMPANY HAS LOST THE PACKAGE CONTAINING THE EXPLANT INFORMATION AND THE EXPLANTED STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 993092

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention