BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3170841 · Received June 14, 2013

    Report

    Report Number
    2953200-2013-01133
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    February 15, 2009
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). CONCLUSIONS: (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN); NO DEVICE FAILURE (PROCEDURE RELATED; UNRELATED TO DEVICE PER INVESTIGATOR¿S DOCUMENTED ASSESSMENT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 6.2 CM. THE PROXIMAL AORTIC NECK WAS 21MM IN DIAMETER AND 27MM IN LENGTH. THE INFRARENAL NECK ANGLE WAS 30 DEGREES. THE DISTAL AORTA WAS 28MM IN DIAMETER. THE LEFT ILIAC ARTERY WAS 13MM IN DIAMETER, AND THE RIGHT ILIAC ARTERY WAS 22MM IN DIAMETER. THE ILIAC ARTERIES WERE MILDLY TORTUOUS WITH NO STENOSIS. IT WAS REPORTED THAT TWO DAYS POST IMPLANT THE PATIENT BEGAN TO EXPERIENCE BILATERAL UPPER LEG NUMBNESS ALONG THE MEDIAL ASPECT OF THE THIGHS DOWN TO THE KNEES. THE PATIENT STATED THAT THIS DID NOT CAUSE A GREAT DEAL OF DISCOMFORT. NO ACTIONS WERE TAKEN, AND THE ADVERSE EVENT WAS NOTED TO BE RESOLVED TWO YEARS POST IMPLANT. THE INVESTIGATOR ASSESSED THE EVENT TO BE RELATED TO THE PROCEDURE BUT NOT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270743 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00235338

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR