BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2100707 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01009
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSIONS: (ENDOLEAK), (SHORT AND SEVERELY ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED THE AORTIC NECK WAS VERY SHORT, 8 MM IN LENGTH, AND SEVERELY ANGULATED. THE STENT GRAFTS WERE IMPLANTED; HOWEVER, THE FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN MODELED THE STENT GRAFT WITH A RELIANT BALLOON. THE ENDOLEAK IMPROVED HOWEVER, DID NOT COMPLETELY RESOLVE. THE PHYSICIAN ELECTED TO MONITOR THE PT IN 30 DAYS AND BELIEVES THE ENDOLEAK WILL RESOLVE WITHOUT FURTHER INTERVENTION. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00853384

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK