BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951124 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00233
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. ANGULATED AORTIC NECK. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH AN AORTIC NECK ANGULATION OF 100 DEGREES. CONCLUSION: ANGULATED SHAPED AORTIC NECK. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH AN AORTIC NECK ANGULATION OF 100 DEGREES.

    Additional Manufacturer Narrative · 1

    METHOD: (FILMS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK ANGLE HAD AN ANGULATION OF 100 DEGREES AND IT WAS 30MM LONG. IT WAS REPORTED THAT INTRA-OPERATIVELY A TYPE I ENDOLEAK WAS OBSERVED. THE STENT GRAFT WAS BALLOONED WITH A RELIANT BALLOON, AS WELL AS WITH 26MM AND 28MM BALLOONS FROM ANOTHER MANUFACTURER. DUE TO THE SUPRA RENAL NECK ANGLE IT WAS NOT POSSIBLE TO FULLY INFLATE THE OTHER MANUFACTURER'S BALLOONS AND THE ENDOLEAK WAS STILL PRESENT. THE DECISION WAS MADE TO IMPLANT A PALMAZ STENT. THIS REDUCED THE ENDOLEAK BUT DID NOT FULLY RESOLVE IT AND THE DECISION WAS MADE TO MONITOR THE PATIENT. A FOLLOW-UP CT SCAN WAS DONE A FEW DAYS LATER AND SHOWED THAT THE ENDOLEAK HAD RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    FILMS WERE RECEIVED AND THEIR EVALUATION WAS COMPLETED. SEVERAL STILL ANGIOGRAM IMAGES DURING IMPLANT WERE REVIEWED. THE PROXIMAL AORTIC NECK IS SEVERELY ANGULATED IN THE VIEW PROVIDED; THE NECK APPEARS OFF-LABEL. THE TIP OF THE DELIVERY SYSTEM IS BIASED AGAINST THE RIGHT LATERAL WALL OF THE SUPRARENAL AORTA. POST-IMPLANT IMAGE SHOWS THAT THE BIFURCATE WAS PLACED JUST BELOW THE RENAL ARTERIES IN THE ANGULATED NECK. THERE IS CONTRAST SEEN IN THE ANEURYSM SAC. THE TYPE OF ENDOLEAK CANNOT BE DETERMINED FROM THE IMAGES PROVIDED. NO OTHER STENT GRAFT ISSUES ARE SEEN. THE FINAL IMAGE POST-IMPLANT WITH THE PALMAZ PLACED INTO THE AORTIC BODY SHOWS A POSSIBLE REDUCTION OF THE AMOUNT OF CONTRAST SEEN IN THE ANEURYSM SAC. THE CAUSE OF THE REPORTED PROXIMAL TYPE I ENDOLEAK COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT THE SEVERELY ANGULATED PROXIMAL NECK CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54636 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03013640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention