BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 19973022 · Received August 13, 2024

    Report

    Report Number
    3007284313-2024-03426
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    August 31, 2020
    Report Date
    December 6, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622368
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. ADDITIONAL INFORMATION INCLUDING PATIENT IMAGING WAS REQUESTED FROM THE STUDY SITE BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR DIRECT EVALUATION BY THE MANUFACTURER. THE ROOT CAUSE OF THE ENDOLEAK CAN THEREFORE NOT BE CONFIRMED. 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 AND ANEURYSM RUPTURE.

    Additional Manufacturer Narrative · 0

    GRT 10-11: 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 ABOVE INFORMATION WAS OBTAINED FROM THE CSD. H3 DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON APRIL 22, 2015, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED WITH COMPUTED TOMOGRAPHY (CTA) WAS 51 MM. ON (B)(6) 2020, THE PATIENT PRESENTED AS AN EMERGENCY REFERRAL DUE TO ANEURYSM EXPANSION AND WAS DIAGNOSED WITH A COVERED RUPTURED ANEURYSM DUE TO A TYPE IA ENDOLEAK. AT THE TIME OF INTAKE, THE ANEURYSM MEASURED 71 X 58 MM (UP FROM 59 X 51 MM AS MEASURED DURING A PREVIOUS FOLLOW UP). THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 67 MM. BOTH OF THE ABOVE MEASUREMENTS WERE DONE USING CTA. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR ON THE SAME DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM DUE TO A TYPE IA ENDOLEAK. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620103 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622368

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other