BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3041722 · Received April 8, 2013

    Report

    Report Number
    2953200-2013-00645
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 20, 2012
    Report Date
    March 13, 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: INHERENT RISK OF PROCEDURE (PARALYSIS); RELATED TO ANOTHER DRUG/DEVICE. CONCLUSIONS: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT.

    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 PROXIMAL AORTIC NECK WAS 23MM IN DIAMETER, THE RIGHT COMMON ILIAC WAS 11-13MM IN DIAMETER AND THE INTERNAL RIGHT ILIAC ARTERY BRANCH WAS 11MM IN DIAMETER. THE COMMON AND INTERNAL LEFT ILIAC DIAMETER WAS 11MM. THE COMBINED PROXIMAL NECK AND ANEURYSM LENGTH WAS 104MM. IT WAS NOTED THAT THERE WAS A TYPE II ENDOLEAK PRESENT. IT WAS REPORTED THE FOLLOWING DAY POST INDEX PROCEDURE THE PATIENT HAD PARAPLEGIA WITH NO OTHER PROGNOSIS. THE PHYSICIAN STATED THAT THE CAUSE OF THE PARAPLEGIA WAS RELATED TO ANOTHER MANUFACTURER'S THORACIC STENT GRAFT. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143106 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR