BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3080282 · Received April 26, 2013

    Report

    Report Number
    2953200-2013-00774
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (FILM EVALUATION)., RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CONICAL AND CALCIFIED NECK). CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (CONICAL AND CALCIFIED NECK).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. REVERSE CONICAL NECK) EVALUATION CODES, CONCLUSIONS: REVERSE CONICAL NECK.

    Description of Event or Problem · 1

    REVIEW OF PRE-IMPLANT CTA SHOW A STRAIGHT NECK WHICH IS CALCIFIED; ESPECIALLY ALONG THE POSTERIOR NECK. THE NECK IS CONICAL SHAPED, RANGING FROM 25 TO 32MM IN DIAMETER. THE 5.7CM MAX AAA DIAMETER IS FILLED WITH THROMBUS (2.5CM FLOW LUMEN), AND THE DISTAL AORTA IS SMALL (13 X 15MM ID) AND VERY CALCIFIED. THE ILIAC ARTERIES ARE ALSO VERY CALCIFIED. IMAGES INTRA-OPERATIVE AND POST-IMPLANT WERE NOT PROVIDED; THE REPORTED PROXIMAL TYPE I ENDOLEAK COULD NOT BE ASSESSED. IT IS POSSIBLE THAT THE CONICAL AND CALCIFIED NECK MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. REVERSE CONICAL AORTIC NECK. IT WAS REPORTED THAT INTRA-OPERATIVELY, A SLOW PROXIMAL TYPE I ENDOLEAK WAS NOTED AFTER STENT GRAFT IMPLANT. THE STENT GRAFT WAS BALLOONED; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PATIENT WILL BE RE-IMAGED IN ONE MONTH. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181104 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03993456

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR