BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2803169 · Received October 24, 2012

    Report

    Report Number
    2953200-2012-02030
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 2, 2010
    Report Date
    September 28, 2012
    Manufacturer
    MEDTRONIC GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DEHYDRATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DEHYDRATION).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 24 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED, THE PROXIMAL AORTIC NECK WAS 20 MM IN DIAMETER AND 60 MM IN LENGTH. THE DISTAL AORTIC NECK WAS 27 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 13 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 15 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 14 AND 12 MM IN DIAMETER RESPECTIVELY. THE RIGHT ILIAC ARTERY WAS MILDLY TORTUOUS WITH 5% STENOSIS. THE PATIENT PRESENTED WITH ISCHEMIA IN THE LEFT LEG. A RECENT CT DEMONSTRATED THAT THERE WAS THE LEFT STENT GRAFT LIMB WAS THROMBOSED. THE PHYSICIAN PERFORMED A THROMBECTOMY AND THE OCCLUSION WAS RESOLVED. THERE WAS NO APPARENT PROBLEM WITH THE GRAFT IN TERMS OF KINKING OR TWISTING HOWEVER IT WAS REPORTED THAT THE PATIENT HAD BECOME DEHYDRATED PRIOR TO REPORTED STENT GRAFT OCCLUSION. THE INVESTIGATOR ASSESSED THAT THIS ADVERSE EVENT WAS RELATED TO THE STUDY DEVICE HOWEVER NOT RELATED TO THE STUDY PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC GALWAY V00532476

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention