BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2161865 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01253
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 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). EVALUATION, RESULTS: (MIGRATION, ENDOLEAK), (CONICAL AORTIC NECK). EVALUATION, CONCLUSIONS: (CONICAL AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN UNK SIZE ABDOMINAL AORTIC ANEURYSM 45 MONTHS AGO. VESSEL MORPHOLOGY FROM THE ORIGINAL IMPLANT WAS REPORTED AS A CONICAL AORTIC NECK OF 24 MM TO 26 MM TO 27 MM; A 45 DEGREE AORTIC NECK ANGLE; MINIMAL ANEURYSM SIZE; STRAIGHT ILIACS WITH MINIMAL CALCIUM AND THROMBUS. IT WAS REPORTED THAT THE ORIGINAL GRAFT WAS PLACED ABOUT 1.5 TO 2 CM AWAY FROM THE RENALS AT THE INITIAL IMPLANT. CURRENTLY, THE STENT GRAFT HAS MIGRATED APPROXIMATELY 3 CM FROM THE RENALS WITH PROXIMAL TYPE 1 ENDOLEAK. THE NECK WAS DILATED AND ELONGATED. THE PHYSICIAN PLANS TO DO AN INTERVENTION AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention