BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 8413644 · Received March 12, 2019

    Report

    Report Number
    2017233-2019-00132
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    December 18, 2018
    Report Date
    March 4, 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 · 1

    (B)(4). USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. PLEASE NOTE, THAT THE DATE OF EVENT WILL BE THE DATE THE ARTICLE WAS PUBLISHED IN THE ¿ANNALS OF VASCULAR SURGERY¿- (B)(6) 2018. PLEASE SEE THE ARTICLE 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) ATTACHED TO THE REPORT.

    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 797 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
    206480 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