BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2912283 · Received January 11, 2013

    Report

    Report Number
    2953200-2013-00074
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 5, 2009
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED, MILDLY TORTUOUS AND ANEURYSMAL ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED, MILDLY TORTUOUS AND ANEURYSMAL ILIAC ARTERIES).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED, MILDLY TORTUOUS AND ANEURYSMAL ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED, MILDLY TORTUOUS AND ANEURYSMAL ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67MM DIAMETER X 155MM LENGTH ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 38 MONTHS AGO. THE AORTIC NECK WAS 29MM IN DIAMETER AND 20MM IN LENGTH WITH AN ANGULATION OF 45 DEGREES. THE RIGHT ILIAC ARTERY DIAMETER WAS 19MM AND THE LEFT WAS 25MM. THE LENGTH OF THE RIGHT ILIAC ARTERY ANEURYSM WAS 40MM AND LEFT ILIAC ARTERY ANEURYSM WAS 45MM. THE RIGHT ILIAC ARTERY HAD MILD TORTUOSITY. THERE WAS 40% STENOSIS IN THE ILIAC ARTERIES BILATERALLY. THERE WAS 10% CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT PROXIMAL NECK. IT WAS REPORTED THAT THERE WAS POSITIONING DIFFICULTIES DUE TO A CALCIFIED AND TORTUOUS ILIAC ARTERY; HOWEVER, IT WAS NOT SPECIFIED WHICH ILIAC ARTERY. IT WAS REPORTED THAT THERE WAS ANEURYSM SIZE FLUCTUATION FROM 72MM APPROXIMATELY ONE WEEK POST IMPLANT TO 69MM AT ONE YEAR POST IMPLANT TO 47MM AT THE 2 YEAR FOLLOW-UP TO FINALLY 78MM APPROXIMATELY THREE WEEKS AGO, WHERE THERE WAS A REPORT OF JUNCTIONAL TYPE III ENDOLEAK LEAK/DISCONNECT REPORTED. THERE WAS NO REPORT ON WHICH STENT GRAFTS SEPARATED AND NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT IS BEING MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED TYPE III ENDOLEAK IS BETWEEN THE BIFURCATED STENT GRAFT/MAIN BODY AND THE CONTRALATERAL LIMB IN RIGHT ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17932 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00289707

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR