BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6628871 · Received June 8, 2017

    Report

    Report Number
    2017233-2017-00291
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 23, 2017
    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). PXC141000/7251519 (B)(4). FURTHER INFORMATION WAS REQUESTED BUT NOT AVAILABLE. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATE THAT CORRECT PRE-TREATMENT PLANNING INCLUDES DETERMINING THE ACCURATE SIZE OF THE PATIENT¿S ANATOMY AND THE PROPER SIZE OF THE ENDOPROSTHESIS. THE LENGTH OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS SHOULD BE SUFFICIENT TO REACH FROM JUST INFERIOR TO THE MOST DISTAL (LOWEST) MAJOR RENAL ARTERY TO NON-ANEURYSMAL TISSUE IN THE COMMON OR EXTERNAL ILIAC ARTERIES. ACCORDING TO THE GORE EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, A FINAL ANGIOGRAPHY NOTED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN PERFORMED A POST-BALLOONING PROCEDURE AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE INITIAL PROCEDURE. EARLY IN (B)(6) 2017, A FOLLOW-UP IMAGING REVEALED THERE WAS A DISTAL TYPE I ENDOLEAK FROM THE GORE EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PXC141000/7251519). ALSO, A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2017, THE PATIENT UNDERWENT THE ADDITIONAL PROCEDURE TO EXTENT THE PXC141000/7251519 DEVICE USING ANOTHER CONTRALATERAL LEG COMPONENT JUST ABOVE THE RIGHT ILIAC ARTERIES BIFURCATION. ACCORDING TO THE PHYSICIAN, THE DISTAL SEALING OF THE RIGHT COMMON ILIAC ARTERY WAS SHORT AND IT CAUSED THE DISTAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. NO ADDITIONAL TREATMENT HAS BEEN PERFORMED FOR THE TYPE II ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409499 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7251519

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R