BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 16286850 · Received February 2, 2023

    Report

    Report Number
    2017233-2023-03681
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    January 19, 2023
    Report Date
    August 31, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING FACILITY CORRECTED (SEE SECTION G.)

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. THERE APPEARS TO BE CONTRAST WITHIN THE PROXIMAL ANEURYSM SAC. THERE APPEARS TO BE CA+ WITHIN THE PROXIMAL LANDING ZONE. THE PROXIMAL ASPECT OF THE ENDOGRAFT APPEARS CONSTRAINED @ 16MM VS ABOVE THE FLOW DIVIDER ~26MM THIS LIKELY REPRESENTS OVERSIZING USED IN THE CASE PLAN. THERE APPEARS TO BE 12MM FROM THE PROXIMAL ENDOGRAFT TO THE VISIBLE CONTRAST WITHIN THE SAC. NO BLOOD IS VISUALIZED OUTSIDE THE DEVICE WITHIN THE PROXIMAL ~12MM SEAL ZONE. THE POOLING AT THE PROXIMAL PORTION OF THE ANEURYSM SAC SEEMS CONSISTENT WITH A TYPE 1 ENDOLEAK. NO CONTRAST IS VISUALIZED WITHIN THE SAC AT THE LEVEL OF THE GATE. THERE ARE DENSITIES PRESENT WITHIN THE ANEURYSM SAC BUT THERE ARE NO NON CONTRAST OR DELAYED IMAGES TO COMPARE. ACCORDING TO THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK.

    Additional Manufacturer Narrative · 0

    DEVICE REMAINS IMPLANTED. 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

    ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT FINAL IMAGING REVEALED NO ENDOLEAK AND THAT THE IMPLANT CONCLUDED WITH A GOOD RESULT. FOLLOW-UP IMAGING ON (B)(6) 2023 SHOWED A TYPE 1A ENDOLEAK. ANEURYSM GROWTH WAS NOT REPORTED. THE ENDOPROSTHESIS WAS LATER EXTENDED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS COMPONENT ON AN UNKNOWN DATE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT FINAL IMAGING REVEALED NO ENDOLEAK AND THAT THE IMPLANT CONCLUDED WITH A GOOD RESULT. FOLLOW-UP IMAGING ON (B)(6) 2023 SHOWED A TYPE 1A ENDOLEAK. ANEURYSM GROWTH WAS NOT REPORTED. THE ENDOPROSTHESIS WAS LATER EXTENDED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS COMPONENT ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381170 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other