BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 2153207 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01193
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 65 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP APPROXIMATELY 1 MONTH AGO, AND IT WAS FOUND THAT THE BIFURCATED STENT GRAFT HAD MIGRATED 5 CM BELOW THE RENALS, RESULTING IN A PROXIMAL TYPE I ENDOLEAK (MFR REPORT # 2953200-2011-01192). AT THE TIME OF MIGRATION, THE ANEURYSM SIZE WAS 5.7 CM, AND THE AORTIC NECK HAD DILATED TO 30-32 MM IN DIAMETER WITH MILD ANGULATION AND 20-30% THROMBUS. THE MIGRATION WAS ATTRIBUTED TO THE AORTIC NECK DILATATION. APPROXIMATELY 2 WEEKS AFTER THE MIGRATION WAS NOTED, THE PHYSICIAN ELECTED TO INTERVENE FOR THE MIGRATION AND ENDOLEAK BY PLACING THREE 28X28X40 ANEURX CUFFS AND A 36X36X70 ENDURANT CUFF PROXIMALLY. IN ADDITION, AN 18X18X85 ANEURX EXTENSION WAS PLACED DISTALLY IN THE LEFT ILIAC TO EXTEND THE IPSILATERAL EXTENSION (MFR REPORT # 2953200-2011-01193) DOWN TO THE LEFT HYPOGASTRIC ARTERY. THERE WAS NO ENDOLEAK; HOWEVER, THE PHYSICIAN DECIDED TO EXTEND THE LIMB AND PROVIDE A LONGER PURCHASE AREA. 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 818599

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention