BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 12861938 · Received November 23, 2021

    Report

    Report Number
    3007284313-2021-01674
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    February 24, 2021
    Report Date
    January 27, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618583
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.  THE PATIENT REFERENCED IN THIS REPORT IS ENROLLED IN A POST MARKET STUDY TO GRT 10-11 EVALUATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS C3 DELIVERY SYSTEM THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT), THE CLINICAL DATA MANAGEMENT SYSTEM (CDMS), IS MEDIDATA RAVE® CLINICAL STUDY DATABASE (CSD), GRT 10-11 MODULE. THE STUDY INVOLVES COMMERCIALLY AVAILABLE DEVICES MARKETED BY GORE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. ADDITIONAL INFORMATION ON THE CAUSE OF THE ENDOLEAK HAS BEEN REQUESTED BUT WAS NOT PROVIDED. THE CAUSE OF THE REPORTED COMPLICATIONS MAY BE THE RESULT OF THE PATIENT¿S DISEASE PROGRESSION OR DISEASE SYMPTOMS, CO-MORBIDITIES AND CONDITIONS AND SURGICAL TECHNIQUE, HOWEVER NO FURTHER INFORMATION RELATED TO THIS WAS REPORTED TO GORE. H6: ADDED ADDITIONAL CONCLUSION CODE.

    Additional Manufacturer Narrative · 0

    H6: COMPONENT CODE 515 ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (PRE-IMPLANT CT DIAMETER 65 MM). ON (B)(6) 2021, A TYPE IB ENDOLEAK WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL AORTIC ENDOGRAFT ((B)(6) 2021 CT DIAMETER: 105 MM). THE PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(6) 2014, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (PRE-IMPLANT CT DIAMETER 65 MM). IT WAS REPORTED THAT ON (B)(6) 2019, A DISTAL TYPE IB ENDOLEAK WAS IDENTIFIED (CT DIAMETER 86 MM). ON (B)(6) 2021, A TYPE IB ENDOLEAK WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL AORTIC ENDOGRAFT ((B)(6) 2021 CT DIAMETER: 105 MM). THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760701 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC231400 00733132618583

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention RMT281416/(B)(6) , PLC231000/(B)(6)