BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2943987 · Received February 5, 2013

    Report

    Report Number
    2953200-2013-00198
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    March 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK, TORTUOUS ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK, TORTUOUS ILIAC ARTERIES).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 5.5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 39 MONTHS AGO. THE AORTIC NECK DIAMETER WAS 18 MM PROXIMALLY AND DISTALLY IT WAS 23 MM WITH A LENGTH OF 15 MM. THE RIGHT AND LEFT ILIAC ARTERIES WERE MILDLY TORTUOUS. IT WAS REPORTED THAT DOPPLER ECHOGRAPHY DONE DURING A ROUTINE FOLLOW-UP VISIT 11 MONTHS POST IMPLANT SHOWED VELOCITIES THAT MAY HAVE BEEN COMPATIBLE WITH THE EXISTENCE OF STENOSIS. APPROXIMATELY THREE WEEKS LATER THE PATIENT PRESENTED WITH SYMPTOMS OF CLAUDICATION AND WAS ADMITTED TO THE HOSPITAL. THERE WAS STENOSIS LOCATED DISTAL TO THE ANCHORING SIDE OF THE RIGHT BRANCH OF THE STENT GRAFT. THIS WAS TREATED WITH A STENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS LATER AND WAS DOING FINE. THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE STUDY DEVICE AND NOT THE STUDY PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MINIMAL STENT GRAFT THROMBUS WAS OBSERVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Description of Event or Problem · 1

    A FILM REVIEW WAS COMPLETED. ULTRASOUND IMAGES FROM A 1-YEAR FOLLOW-UP STUDY WERE REVIEWED. TRANSVERSE IMAGES COULD NOT CONFIRM OR RULE OUT THE REPORTED STENOSIS. IMAGES SHOW POSSIBLE THROMBUS IN ONE OF THE LIMBS, BUT THIS COULD ALSO BE AN ARTIFACT. NO OBVIOUS STENT GRAFT INTEGRITY ISSUES WERE OBSERVED. CTA'S WERE NOT PROVIDED TO ASSIST WITH THE VISUALIZATION AND CAUSE OF THE REPORTED STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48010 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00346320

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention