BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1071352 · Received July 8, 2008

    Report

    Report Number
    2953200-2008-00525
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (GRAFT).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED AND NO COMPLICATIONS WERE REPORTED AT THE TIME OF IMPLANT. IT WAS REPORTED THAT THE ANEURYSM WAS VERY PULSATILE ON THE RIGHT SIDE OF THE AORTA LIKE A LARGE GOLF BALL PROTRUDING OUT. THE PHYSICIAN MODELLED THE STENT GRAFT WITH A RELIANT BALLOON (COMPLETELY WITHIN THE STENT GRAFT) THE PHYSICIAN DID NOT OVER INFLATE THE BALLOON. AFTER THE INFLATION OF THE BALLOON, THE ANGIOGRAM REVEALED THAT THE STENT RING WAS PROTRUDING INTO THE ANEURYSM, THERE WAS A BROKEN SUTURE AND IT APPEARED THAT THERE WAS A TEAR IN THE GRAFT MATERIAL, THE TEAR WAS RIGHT BELOW THE FIGURE 8 MARKER ON THE OUTSIDE OF THE STENT GRAFT. THE PHYSICIAN ELECTED TO RELINE THE GRAFT WITH AN ILIAC LIMB. THE PHYSICIAN STATED THAT HE BELIEVES THAT DUE TO THE CONFIGURATION OF THE ANEURYSM WHEN THE PHYSICIAN BALLOONED, THE STENT GRAFT WAS PUSHED INTO THE ANEURYSM. THE PHYSICIAN STATED THAT IF THE CASE COULD HAVE BEEN PUSHED INTO THE ANEURYSM. THE PHYSICIAN STATED THAT IF THE CASE COULD HAVE BEEN REPEATED HE WOULD HAVE ANGIOPLASTY ONLY ABOVE AND BELOW THE ANEURYSM AND NOT WITHIN THE 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 V00107767

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention