BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 11479292 · Received March 15, 2021

    Report

    Report Number
    3007284313-2021-01315
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    May 14, 2020
    Report Date
    February 25, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT DEMOGRAPHICS: PROVIDED MEAN AGE WAS 71.7 YEARS OLD AND GENDER OF ARTICLE IS 56 MALES AND 4 FEMALES, MEAN WEIGHT IS 61.4 KG. PATIENT INFORMATION WILL REFLECT 72-YEAR-OLD MALE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE WAS UNABLE TO BE CONDUCTED AS NO LOT NUMBER WAS AVAILABLE. IT IS UNKNOWN IF THESE ADVERSE EVENTS WERE RELATED TO THE EXCLUDER DEVICES. BECAUSE OUT OF THE REMAINING 60 PATIENTS WITH FOLLOW-UP, ONLY 2 (3.3%) WERE TREATED WITH EXCLUDER DEVICE AT THE INITIAL PROCEDURE, ALL THE OTHERS WERE TREATED WITH NON-GORE DEVICES. INFORMATION WAS NOT MADE AVAILABLE. IMPLANT DATE WAS NOT MADE AVAILABLE. CAUSE OF THE EVENT CANNOT BE ESTABLISHED BASED ON THE AVAILABLE INFORMATION. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. ARTICLE CITATION: TYPE 2 ENDOLEAKS: COMMON AND HARD TO ERADICATE YET BENIGN? LIANG MENG LOY, JASMINE MING ER CHUA, TZE TEC CHONG, ET AL. HTTPS://DOI.ORG/10.1007/S00270-020-02497-3 CARDIOVASC INTERVENT RADIOL (2020) 43:963¿970. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS FROM THE ARTICLE: MEAN AGE IS 71.7 YEARS, MEAN WEIGHT IS 61.4 KG, 56 MALES AND 4 FEMALES.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE ¿TYPE 2 ENDOLEAKS: COMMON AND HARD TO ERADICATE YET BENIGN?¿ PUBLISHED IN CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2020) 43:963¿970 ON 14 MAY 2020. THE AUTHORS: LIANG MENG LOY, JASMINE MING ER CHUA, TZE TEC CHONG, ET AL. THIS WAS A STUDY OF PATIENTS WHO UNDERWENT ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) BETWEEN FEBRUARY 2006 AND DECEMBER 2016. A TOTAL OF 156 PATIENTS UNDERWENT EVAR, OF WHICH 67 DEVELOPED TYPE II ENDOLEAKS. OUT OF THE REMAINING 60 PATIENTS WITH FOLLOW-UP, 2 (3.3%) WERE TREATED WITH EXCLUDER DEVICE AT THE INITIAL PROCEDURE. 45 (75.0%) WERE TREATED WITH ZENITH DEVICE, 7 (11.7%) WERE TREATED WITH ENDURANT DEVICE, 6 (10.0%) WERE TREATED WITH OTHERS DEVICE. 41 PATIENTS HAD ISOLATED TYPE II ENDOLEAK, 19 HAD CONCOMITANT TYPE I ENDOLEAK AND/OR TYPE III ENDOLEAK. AMONGST THOSE WITH PERSISTENT TYPE II ENDOLEAKS ASSOCIATED WITH SAC GROWTH (N = 17), 14 UNDERWENT INTERVENTION, OF WHICH 7 RECEIVED >1 EMBOLIZATION PROCEDURE. 1 PATIENT WHO WAS TREATED WITH EXCLUDER DEVICE AT THE INITIAL PROCEDURE BUT WITH NO SPECIFIC INDIVIDUALLY IDENTIFIABLE PATIENT INFORMATION IS CAPTURED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378019 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention