BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4197912 · Received October 23, 2014

    Report

    Report Number
    2953200-2014-02171
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. INGUINAL FIELD BLOCK FOR FEMORAL ARTERY EXPOSURE DURING ENDOVASCULAR ANEURYSM REPAIR. FRANCESCO SETACCI, PASQUALINO SIRIGNANO, VASILIKI KAMARGIANNI, GIUSEPPE GALZERANO, GIANMARCO DE DONATO, PASQUALE BIANDOLINO, ALESSANDRO CAPPELLI, AND CARLO SETACCI J ENDOVASC THER. 2013 ,20:655-662. ON UNKNOWN DATES BETWEEN JANUARY 2004 TO JUNE 2012, A TALENT AND AN ENDURANT STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, MIGRATION, OCCLUSION, RUPTURE, INFECTION, MI, ENDOLEAKS, ANEURYSM ENLARGEMENT. PURPOSE: TO ANALYZE THE FEASIBILITY AND OUTCOMES OF AN INGUINAL FIELD BLOCK (IFB) FOR FEMORAL ARTERY EXPOSURE IN PATIENTS UNDERGOING ELECTIVE ENDOVASCULAR ANEURYSM REPAIR (EVAR). METHODS: BETWEEN JANUARY 2004 AND JUNE 2012, 784 PATIENTS (597 MEN; MEAN AGE 76 YEARS) UNDERWENT ELECTIVE EVAR VIA SURGICAL CUTDOWN TO THE COMMON FEMORAL ARTERIES. THE DATA FROM THESE PROCEDURES WERE RETROSPECTIVELY ANALYZED TO DETERMINE THE TECHNICAL FEASIBILITY OF IFB, NEED FOR CONVERSION TO GENERAL ANESTHESIA, MORTALITY, AND COMPLICATION RATE. RESULTS: IFB WAS SUCCESSFULLY PERFORMED IN 768 (97.9%) PATIENTS. CONVERSION FROM IFB TO GENERAL ANESTHESIA WAS NECESSARY IN 11 (1.4%) PATIENTS OWING TO PATIENT DISCOMFORT (N=3, 0.4%), ANXIETY (N=5, 0.6%), AND PERSISTENT PATIENT MOVEMENT (N=3, 0.4%). THE REMAINING 5 (0.7%) PATIENTS UNDERWENT EVAR UNDER GENERAL ANESTHESIA BECAUSE THEY REFUSED IFB. TECHNICAL SUCCESS OF EVAR WAS 99.7%; THE MEAN OPERATION TIME WAS 84 MINUTES AND THE RADIATION TIME WAS 13 MINUTES. THE MEAN HOSPITAL STAY WAS 3.7 DAYS; NO PATIENT REQUIRED INTENSIVE CARE. AT 6 MONTHS, THERE WERE NO REPORTS OF LOCAL/SYSTEMIC COMPLICATIONS RELATED TO IFB, SUCH AS INFECTION, SEROMA, HEMATOMA, NERVE INJURY, OR ALLERGIC/TOXIC REACTIONS. CONCLUSION: OUR STUDY DEMONSTRATED THAT PERFORMING EVAR WITH FEMORAL CUTDOWN UNDER IFB IS A FEASIBLE, SAFE, AND EFFECTIVE SURGICAL AND ANESTHETIC COMBINATION, WITH VERY LITTLE NEED FOR CONVERSION TO GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674907 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention