BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2974620 · Received February 22, 2013

    Report

    Report Number
    2953200-2013-00340
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANGULATED AORTIC NECK); UNAPPROVED USE OF DEVICE (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH SEVERELY ANGULATED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANGULATED AORTIC NECK); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH SEVERELY ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.5 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE VESSELS WERE NON-PROHIBITIVE. THE AORTIC NECK WAS ANGULATED AT > 60 DEGREES. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE IT WAS NOT POSSIBLE TO GET A SEAL AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED RESULTING IN A TYPE I ENDOLEAK. A 282849 ENDURANT AORTIC CUFF WAS DEPLOYED IN ATTEMPT TO OBTAIN A SEAL; HOWEVER THIS WAS UNSUCCESSFUL AND THE TYPE I ENDOLEAK DID NOT RESOLVE. THE FOLLOWING DAY THE PATIENT WAS BROUGHT TO THE RADIOLOGY LAB TO GET BETTER IMAGING. A 323249 ENDURANT CUFF WAS IMPLANTED BUT IT DID NOT RESOLVE THE ENDOLEAK. NO FURTHER INTERVENTION WAS PERFORMED. A POST-OPERATIVE CT ONE WEEK POST IMPLANT SHOWED THE ENDOLEAK RESOLVED. AN ADDITIONAL CT SCAN WAS PERFORMED A FEW DAYS LATER SHOWED THE ENDOLEAK WAS ONCE AGAIN VISIBLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78158 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01722234

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention