BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3072735 · Received April 23, 2013

    Report

    Report Number
    2953200-2013-00755
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: OCCLUSION. LACK OF INFORMATION (CAUSE OF OCCLUSION IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE OF OCCLUSION IS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 49MM. THE DIAMETER OF THE PROXIMAL NECK WAS 20MM. THE DIAMETER OF THE ANEURYSM ENTRANCE WAS 20MM. THE PROXIMAL NECK LENGTH WAS 14MM AND THE DIAMETER OF THE RIGHT COMMON ILIAC WAS 15MM. THE RIGHT INTERNAL ILIAC DIAMETER WAS 8MM, AND THE RIGHT COMMON ILIAC LENGTH WAS 33MM. THE VESSEL DIAMETER OF THE LEFT COMMON ILIAC WAS 15MM AND THE LEFT INTERNAL ILIAC DIAMETER WAS 10MM. THE LEFT COMMON ILIAC ARTERY LENGTH WAS 45MM. THE MINIMUM VESSEL DIAMETER OF THE RIGHT EXTERNAL ILIAC WAS 7MM, AND THE MINIMUM DIAMETER OF THE LEFT EXTERNAL ILIAC WAS 7MM. THE STENT GRAFT WAS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED. THE MEDICAL HISTORY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED A RIGHT LIMB OCCLUSION. THE PHYSICIAN RELATED THE OCCLUSION TO EMBOLISM FROM A THROMBUS CAUSED BY ABSTRACTION. THROMBUS REMOVAL WOULD BE PERFORMED, BUT THE PHYSICIAN DID NOT CONFIRM ADDITIONAL TREATMENT AT THIS TIME. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS; IT WAS REPORTED THAT SEVEN MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH AN OCCLUSION OF THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT AND THE IPSILATERAL EXTENSION ON THE RIGHT SIDE. A THROMBECTOMY WAS PERFORMED THREE DAYS AFTER THE EVENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175312 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention