BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3200142 · Received July 1, 2013

    Report

    Report Number
    2953200-2013-01222
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: SURGICAL INTERVENTION. CONCLUSION: SURGICAL INTERVENTION.

    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. THE RENAL ARTERIES WERE CORRECTLY MARKED ON THE SCREEN AND THE BIFURCATED STENT GRAFT DELIVERY SYSTEM WAS INSERTED WITHOUT COMPLICATION AND ADVANCED. THE FIRST THREE STENT RINGS WERE DEPLOYED WITHOUT ISSUE WITH PLACEMENT OF THE STENT GRAFT AT THE INTENDED LOCATION. THE STENT GRAFT DEPLOYMENT HAD BEEN COMPLETED TO THE LEVEL OF THE CONTRALATERAL GATE. THE CONTRALATERAL GATE WAS CANNULATED AND THE CONTRALATERAL LIMB WAS IMPLANTED, THEN DEPLOYMENT OF THE IPSILATERAL LIMB WAS DONE. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE A FINAL PICTURE WAS TAKEN AND THE STENT GRAFT WAS FOUND TO HAVE COVERED THE RENAL ARTERIES. THE PHYSICIAN DOES NOT KNOW AT WHAT POINT THAT HAPPENED, BUT SURMISED THAT THIS HAPPENED SOMETIME BETWEEN WHEN THE FIRST THREE STENT RINGS WERE DEPLOYED AND WHEN THE SUPRA-RENAL STENTS WERE DEPLOYED. THE DECISION WAS MADE TO EXPLANT THE STENT GRAFTS. POST EXPLANT THE PATIENT WAS PRODUCING URINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297749 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04041784

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention