BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 7715459 · Received July 24, 2018

    Report

    Report Number
    3007284313-2018-00212
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    October 20, 2018
    Report Date
    September 26, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ADDITIONAL DEVICE PLC271000, UDI: (B)(4). THIS DEVICE WAS ALSO INVESTIGATED SINCE IT IS NOT CLEAR WHICH DEVICE WAS ASSOCIATED WITH THE TYPE 1B ENDOLEAK.

    Additional Manufacturer Narrative · 0

    RESULTS CODE 2: 213 A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. H.6. CONCLUSION CODE 1: 22: 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, ANEURYSM ENLARGEMENT AND REOPERATION.

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE: ADDED.

    Description of Event or Problem · 0

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST MARKET PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN DATA ON DEVICE PERFORMANCE AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH GORE ENDOVASCULAR AORTIC PRODUCTS THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-11 MODULE. THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT A BENTALL AND ENDOVASCULAR PROCEDURE FOR A TYPE B DISSECTION REPAIR USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017 THE MAXIMUM AORTIC DIAMETER WAS 67MM. ON (B)(6) 2017 THE MAXIMUM AORTIC DIAMETER WAS 75MM. ON (B)(6) 2018 THE PATIENT EXHIBITED A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2018 THE PATIENT UNDERWENT REPAIR OF THE RIGHT COMMON ILIAC ARTERY WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018 THE PATIENT WAS RECOVERING FROM HIS SURGERY WITH SEVERE DECONDITIONING.

    Description of Event or Problem · 1

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST MARKET PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN DATA ON DEVICE PERFORMANCE AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH GORE ENDOVASCULAR AORTIC PRODUCTS THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-11 MODULE. THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A BENTALL AND ENDOVASCULAR PROCEDURE FOR A TYPE B DISSECTION REPAIR USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018 THE PATIENT EXHIBITED A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2018 THE PATIENT UNDERWENT REPAIR OF THE RIGHT COMMON ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555211 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11085579

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R