BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4214089 · Received October 30, 2014

    Report

    Report Number
    2953200-2014-02239
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 4, 2014
    Report Date
    December 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 AN OCCLUDED RIGHT COMMON ILIAC AND RIGHT EXTERNAL ILIAC ARTERY. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF TINGLING IN THEIR RIGHT LEG TWO WEEKS POST INDEX PROCEDURE. THE PATIENT PRESENTED EMERGENTLY THAT NIGHT DUE TO THE TINGLING WORSENING. A CT SHOWED AN OCCLUDED RIGHT COMMON ILIAC AND RIGHT EXTERNAL ILIAC ARTERY. FLOW RECONSTITUTED IN THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT HAD A THROMBECTOMY. MULTIPLE PASSES WERE ATTEMPTED AND CLOT WAS REMOVED. HOWEVER, FLOW COULD NOT BE RESTORED ADEQUATELY. THE PHYSICIAN ELECTED TO DO A FEM-FEM BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    UPDATED INFORMATION: THE RIGHT PROXIMAL ILIAC IS 10.8 MM IN DIAMETER, THE PROXIMAL ANEURYSM IS 12.4 MM IN DIAMETER. THE LENGTH OF THE PROXIMAL SEAL ZONE IS 19 MM. THE RIGHT COMMON ILIAC LENGTH IS 87 MM.

    Description of Event or Problem · 1

    THE PATIENT IS FINE. THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694929 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04256006

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention