BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 8471901 · Received April 1, 2019

    Report

    Report Number
    2017233-2019-00192
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    September 30, 2016
    Report Date
    April 10, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS THIS WAS INFORMATION COLLECTED DURING A REVIEW OF DATA BETWEEN DATES OF OCTOBER 2013 AND SEPTEMBER 2016, THE AGE AND SEX REPORTED IN THIS MEDWATCH ARE AVERAGES.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. ADDITIONALLY, PER IFU, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THE FOLLOWING FINDINGS WERE NOTED: TOSHIYA NISHIBE, MD ET AL., "CLINICAL AND MORPHOLOGICAL OUTCOMES IN ENDOVASCULAR AORTIC REPAIR OF ABDOMINAL AORTIC ANEURYSM USING GORE C3 EXCLUDER: COMPARISON BETWEEN PATIENTS TREATED WITHIN AND OUTSIDE INSTRUCTIONS FOR USE" IN ANNALS OF VASCULAR SURGERY (2019) (AVAILABLE ONLINE ON FEBRUARY 23, 2019). BETWEEN OCTOBER 2013 AND SEPTEMBER 2016, 109 (91 MEN AND 18 WOMEN, WITH A MEAN AGE OF 77.0 YEARS) PATIENTS UNDERWENT AN ENDOVASCULAR AORTIC REPAIR USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO REPAIR INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE ARTICLE STATES THAT ONE PATIENT WAS IDENTIFIED WITH A TYPE II ENDOLEAK. THE PATIENT UNDERWENT A RE-INTERVENTION AT 294 DAY AFTER THE INITIAL PROCEDURE TO REPAIR THE ENDOLEAK BY TRANSARTERIAL COIL AND NBCA EMBOLIZATION. (P16, 231-235/TABLE 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261645 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R