BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3132751 · Received May 29, 2013

    Report

    Report Number
    2953200-2013-01016
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, DEATH, RENAL FAILURE, ENDOLEAK, EMBOLISM); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; TYPE II ENDOLEAK, RENAL FAILURE); (INSUFFICIENT INFORMATION; CAUSE OF THE THROMBUS WITHIN THE STENT GRAFT IS UNKNOWN). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; TYPE II ENDOLEAK, RENAL FAILURE); KNOWN INHERENT RISK OF A PROCEDURE (OCCLUSION, DEATH, RENAL FAILURE, ENDOLEAK, EMBOLISM); (INSUFFICIENT INFORMATION; CAUSE OF THE THROMBUS WITHIN THE STENT GRAFT IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTA WAS 31 MM IN DIAMETER AND 55 MM IN LENGTH. DISTAL AORTA WAS 27 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 15 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 13 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 10 MM IN DIAMETER. THE RIGHT AND LEFT ILIAC ARTERIES WERE MILDLY TORTUOUS. POST INDEX PROCEDURE, A TYPE II ENDOLEAK WAS NOTED AND WAS LEFT UNCORRECTED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE ANEURYSM WAS 89 MM IN DIAMETER. A TECHNICAL OBSERVATION WAS NOTED. THERE WAS MINIMAL THROMBUS PRESENT IN THE BODY OF THE STENT GRAFT; SPECULATION IS THAT THE PATIENT SUFFERED BILATERAL POPLITEAL ARTERY EMBOLI FROM THE SMALL DEGREE OF THROMBUS IN THE BODY OF THE STENT GRAFT. THE PATIENT HAD RENAL FAILURE RESULTING IN DEATH. BLOOD WORK WAS DONE AND CREATININE FOUND TO BE 465 UMOL/L. (PRE EVAR WAS 208). THIS IS LIKELY DUE TO LONG TERM CYCLOSPORINE USE. THE PATIENT DID NOT WISH TO RECEIVE ANY TREATMENT. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235025 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00508131

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death