BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17419974 · Received July 28, 2023

    Report

    Report Number
    3013164176-2023-01772
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 14, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618545
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, ANEURYSM ENLARGEMENT, AND REOPERATION. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED ON (B)(6) 2023. IMAGES SHOW LACK OF DISTAL DEVICE APPOSITION IN THE RCI. CONTRAST IS VISUALIZED OUTSIDE THE IMPLANTED DEVICES. THEREBY, CONFIRMING A DISTAL TYPE I ENDOLEAK. MAXIMUM RCI DIAMETER APPEARS TO BE 33MM.

    Additional Manufacturer Narrative · 0

    H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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 WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 - RLT311413) AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEGS -PLC271200 AND PLC201200). REPORTEDLY, ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 9 INFRARENAL TO TREAT A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC WHERE THE CONTRALATERAL LEG (PLC271200) LIMB WAS PLACED AS THERE WAS ANEURYSM GROWTH AND MEASURED AS 33MM AROUND THE 27MM BELL BOTTOM, THUS, THE PLANNED REINTERVENTION WAS TO COIL EMBOLIZE AND COVER THE RIGHT HYPOGASTRIC ARTERY AND THEN EXTENDED DISTALLY WITH A CONTRALATERAL LEG (PLC141400). ENDOLEAK WAS RESOLVED AND PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 - RLT311413) AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEGS -PLC271200 AND PLC201200). REPORTEDLY, ON (B)(6) 2023 THE PATIENT WILL UNDERGO A REINTERVENTION TO TREAT A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC WHERE THE 27MM LIMB WAS PLACED AND PLAN IS TO COIL AND COVER THE RIGHT HYPOGASTRIC ARTERY AND EXTEND WITH A 14.5MM LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316875 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618545

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Required Intervention| H