BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 12331952 · Received August 17, 2021

    Report

    Report Number
    3007284313-2021-01549
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    August 13, 2021
    Report Date
    December 10, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622467
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE 4755 (G07001) PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    H6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    G1. MANUFACTURING SITE NAME AND ADDRESS: MEDICAL PHOENIX 2. 32470 N NORTH VALLEY PKWY. PHOENIX, AZ 85085.

    Additional Manufacturer Narrative · 1

    THE CAUSES AND EFFECTS OF TYPE II ENDOLEAKS, ARE WELL DOCUMENTED. WHEN A TYPE II ENDOLEAK IS PRESENT, THE SEAL AROUND THE GRAFT ATTACHMENT ZONES CAUSES A PRESSURE DROP WITHIN THE SAC WHICH, IN TURN, CAUSES THE RETROGRADE FLOW OF BLOOD FROM SMALL BRANCH VESSELS BACK INTO THE ANEURYSM SAC. HISTORICAL ENDOVASCULAR DATA HAS DEMONSTRATED THIS EVENT IS NOT SPECIFIC TO INDIVIDUAL ENDOVASCULAR DEVICE DESIGN. RATHER, SUCH DATA HAS DEMONSTRATED THIS PHENOMENON IS LIKELY THE RESULT OF THE ANATOMY IN WHICH THE ENDOVASCULAR PROCEDURE IS BEING PERFORMED AND THE PRINCIPLES OF OPERATION OF ENDOVASCULAR STENT GRAFTS. THIS INCLUDES THE SIZE AND NUMBER OF BRANCH VESSELS ORIGINATING FROM THE EXCLUDED ANEURYSM SAC, AND THE AMOUNT OF COLLATERAL VESSELS CAPABLE OF SUPPLYING BLOOD TO THEM. THE CLINICAL IMPLICATION OF TYPE II ENDOLEAKS CAN BE THE PREVENTION OF SAC THROMBOSIS, CONTINUED ANEURYSM SAC EXPANSION, POSSIBLE ANEURYSM RUPTURE, AND DEATH. TYPE II ENDOLEAKS ARE REPORTED IN 10¿25% OF ABDOMINAL ENDOGRAFT CASES AND IN 1¿20% OF THORACIC ENDOGRAFT CASES. THEY MAY BE DIAGNOSED AT THE TIME OF GRAFT IMPLANTATION, AT THE FIRST FOLLOW-UP IMAGING STUDY, OR IN A DELAYED FASHION MONTHS OR YEARS AFTER THE EVAR/TEVAR PROCEDURE. THESE LEAKS HAVE ALSO BEEN NOTED TO SPONTANEOUSLY RESOLVE AND, AT TIMES, REAPPEAR ON SUBSEQUENT STUDIES. 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. SPECIFICALLY, THE IFU WARNS THAT ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE ANEURYSM MEASURED 61 MM. ON (B)(6) 2021, A TYPE II ENDOLEAK WAS DISCOVERED AND TREATED BY MEANS OF EXPLANTATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH AORTO-BI-ILIAC BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227601 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT261416 00733132622467

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male