BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18222926 · Received November 28, 2023

    Report

    Report Number
    3013164176-2023-01910
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 28, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6: CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. H.6: CODE B20: DEVICE REMAINS IMPLANTED AND THEREFORE NOT AVAILABLE FOR DIRECT ANALYSIS. H.6.: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND OR REQUIRE INTERVENTION, INCLUDE, BUT ARE NOT LIMITED TO: RUPTURES OF THE AORTIC VESSEL AND SURROUNDING VASCULATURE, BLEEDING, HEMATOMA. H.6.: CODE D1102: PER PHYSICIAN REPORT: THE CAUSE OF THE EVENT MAY HAVE BEEN EXCESSIVE BALLOONING AT THE HIGHLY CALCIFIED AREA. 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

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR A LEFT INTERNAL ILIAC ARTERY ANEURYSM. COIL EMBOLIZATION FOR THE INTERNAL ILIAC ARTERY WAS PERFORMED AS AN ADJUNCT PROCEDURE. AFTER DEPLOYING A ENDOPROSTHESIS AND BALLOONING USING A NON-GORE BALLOON (HYPERFLEX¿, MEDICO'S HIRATA INC.), THE PATIENT BLOOD PRESSURE DECREASED. ANGIOGRAPHY SHOWED A RUPTURE OF THE LEFT COMMON ILIAC ARTERY NEAR THE PROXIMAL END OF THE ENDOPROSTHESIS. FOR REPAIR, TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED FROM THE ORIGIN OF THE LEFT COMMON ILIAC ARTERY. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING THAT THE BLEEDING HAD STOPPED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: THE CAUSE OF THE EVENT MAY HAVE BEEN EXCESSIVE BALLOONING AT THE HIGHLY CALCIFIED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537833 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Other| R