BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3781386 · Received April 30, 2014

    Report

    Report Number
    2953200-2014-00883
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 4.9 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 18-22 MM IN DIAMETER AND 16 MM IN LENGTH. THE LEFT AND RIGHT COMMON ILIAC ARTERIES WERE 12 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 5.8 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 6.7 MM IN DIAMETER. THE PATIENT HAD A REVERSED TAPERED AORTIC NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER IMPLANTATION OF THE MAIN BODY AND LIMBS, ANGIOGRAPHY CONFIRMED A PROXIMAL TYPE I ENDOLEAK AND A TYPE IV ENDOLEAK. THE PHYSICIAN THEN IMPLANTED OTHER MANUFACTURER¿S AORTIC CUFF REDUCING THE AMOUNT OF THE ENDOLEAK HOWEVER, DID NOT RESOLVE. THE PHYSICIAN COMMENTED THAT IT WAS AN ACCEPTABLE RESULT BECAUSE IT WAS THE CASE OF REVERSED TAPER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260273 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04047007

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention