BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17552042 · Received August 15, 2023

    Report

    Report Number
    3013164176-2023-01800
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    June 19, 2023
    Report Date
    November 1, 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

    B3/B4/B5/B6: ADDITIONAL INFORMATION ADDED REGARDING SUCCESSFUL TREATMENT OF THE ENDOLEAK. G2: REPORT SOURCE CORRECTED TO FOREIGN. G3/G4: DATE RECEIVED REFLECTS THE DATE GORE BECAME AWARE OF THE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C19: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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 FIRST RE-INTERVENTION OCCURRED ON JULY 31, 2023. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND A CONTRALATERAL LEG STENT GRAFT WAS IMPLANTED TO EXTEND TO THE RIGHT EXTERNAL ILIAC ARTERY. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESES, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AFTER DEPLOYING THE TRUNK-IPSILATERAL LEG COMPONENT, TWO CONTRALATERAL LEG COMPONENTS WERE IMPLANTED, A RIGHT LEG (PLC271400J) AND A LEFT LEG (PLC231200J). AFTER IMPLANTATION, BILATERAL DISTAL TYPE I ENDOLEAKS WERE OBSERVED. ADDITIONAL TOUCH-UPS WERE PERFORMED, HOWEVER BOTH ENDOLEAKS REMAINED DUE TO HIGH CALCIFICATION. THE PHYSICIAN DECIDED TO MONITOR THEM AND EXPECTED THEM TO DISAPPEAR AFTER THE TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE BUT TWO WEEKS LATER, A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED THAT THE BILATERAL DISTAL TYPE I ENDOLEAK REMAINED. A STAGED RE-INTERVENTION WAS PLANNED. THE FIRST RE-INTERVENTION ON (B)(6) 2023 WAS PLANNED TO EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY AND IMPLANT AN ADDITIONAL STENT GRAFT TO EXTEND TO A RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN STATED THAT THE LANDING ZONES WERE LONGER, BUT THE STENT GRAFTS DID NOT FIT WELL INTO THE LANDING ZONES DUE TO HIGH CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246926 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention