BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3150718 · Received June 6, 2013

    Report

    Report Number
    2953200-2013-01082
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 4, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (STENT GRAFT OCCLUSION). (HIT).

    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. ANEURYSM AND VESSEL MORPHOLOGY WERE DESCRIBED AS NORMAL. IT WAS REPORTED THAT ONE DAY AFTER THE PROCEDURE THE PATIENT HAD A COLD RIGHT LEG. THE MID IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE OCCLUDED WITH THROMBUS. THIS DID NOT INVOLVE THE AORTIC BIFURCATION OR THE CONTRALATERAL LIMB. THE RIGHT LIMB WAS DE-CLOTTED AND THE DISTAL END OF THE IPSILATERAL LIMB WAS STENTED AND EXTENDED INTO THE COMMON ILIAC ARTERY WITH AN UNKNOWN MANUFACTURER¿S STENT. THIS RESOLVED THE OCCLUSION AT THAT TIME AND THE PATIENT WAS FINE. ON AN UNKNOWN DATE THE PATIENT PRESENTED TO A GENERAL PHYSICIAN WITH THE SAME COLD LEG ON THE RIGHT. THE IPSILATERAL LIMB WAS FOUND TO HAVE OCCLUDED AGAIN. THE OCCLUSION WAS ATTEMPTED TO BE DE-CLOTTED; HOWEVER, THIS WAS UNSUCCESSFUL. THE DECISION WAS MADE TO PERFORM A FEM-FEM BYPASS AND THIS SUCCESSFULLY RESTORED FLOW TO THE RIGHT SIDE. THE PHYSICIAN STATED THAT THE OCCLUSION WAS DUE TO HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) AND NOT RELATED TO THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATES THAT THE SECOND CLOTTING EVENT OCCURRED ONE WEEK AFTER THE FIRST EPISODE. THE PATIENT NOW ALSO STATES THAT THEY ARE ON COUMADIN, AND HAS HAD MULTIPLE SFA CLOTS. THE PATIENT IS SCHEDULED TO SEE THE PHYSICIAN TO TREAT ANOTHER CLOT THAT HAS JUST DEVELOPED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL EXPERIENCING GOOD AMOUNT OF PAIN SINCE THE PREVIOUSLY REPORTED SECONDARY INTERVENTION (FEM-FEM BYPASS PROCEDURE). THE PREVIOUSLY REPORTED CLOT IN STENT GRAFT IS CONTINUING. THE PATIENT HAD SEVERAL THROMBOSES OF THE FEM-FEM GRAFT AS WELL. THE PHYSICIAN THOUGHT THAT THE PATIENT MAY HAVE AN UNDIAGNOSED HYPERCOAGULABLE SYNDROME, AS THEY NEVER HAD A GOOD REASON WHY THE RIGHT LIMB OF THE PATIENT'S EVAR THROMBOSED TWICE, OR WHY THEIR FEM-FEM HAS THROMBOSED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249868 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01716152

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention