BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17205781 · Received June 26, 2023

    Report

    Report Number
    3007284313-2023-02577
    Event Type
    Injury
    Date Received
    June 26, 2023
    Date of Event
    February 24, 2023
    Report Date
    June 26, 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. TYPE OF INVESTIGATION CODE B14: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. TYPE OF INVESTIGATION CODE B20: THE DEVICE WAS DISCARDED AT THE FACILITY AND IS NOT AVAILABLE FOR ANALYSIS. TWO ADDITIONAL GORE® EXCLUDER® DEVICES ARE CAPTURED ON THIS REPORT. THESE WERE EXPLANTED, BUT THERE IS NO ALLEGATION OF DEFICIENCY AGAINST THEM: #1. SN: (B)(6). UDI: (B)(4). CATALOG: PLC201000J. #2. SN: (B)(6). UDI: (B)(4). CATALOG: PLC181400J. 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, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT WAS ADMITTED WITH BILATERAL LOWER EXTREMITY ISCHEMIA DUE TO AN OCCLUSION BECAUSE OF A COMPRESSION OF PROXIMAL SIDE OF RLT231412J. A PROXIMAL TYPE I ENDOLEAK, AN ENLARGEMENT AND A PULSATION OF THE ANEURYSM WERE OBSERVED, AND EMERGENCY AXILLO-BI-FEMORAL BYPASS WAS PERFORMED. ON (B)(6) 2023, A Y-GRAFT REPLACEMENT WAS PERFORMED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN STATED THAT IT IS POSSIBLE THAT BLOOD FLOW FROM THE SLIGHT BIRD BEAK, A LACK OF APPOSITION, ON THE PROXIMAL EDGE OF THE DEVICE FLOWED INTO THE ANEURYSM AND CRUSHED THE PROXIMAL SIDE OF THE DEVICE. THE MOMENT THE PATIENT STOOD UP FROM HIS CROUCHED POSITION, HE FELT NUMBNESS IN HIS LEGS AND WAS ADMITTED TO THE HOSPITAL. THE PERIPHERAL BLOOD VESSELS WERE COMPRESSED IN THE CROUCHED POSITION AND THE PROXIMAL BLOOD PRESSURE ROSE, WHICH MAY HAVE CAUSED THE PROSOMAL DEVICE TO COLLAPSE. IT IS POSSIBLE THAT THE LACK OF APPOSITION MAY HAVE BEEN CREATED BY THE IMPLANTATION THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED ON THE RIGHT SIDE, OPPOSITE OF GORE'S SUGGESTION, FOR EASE OF CONTRALATERAL CANNULATION AND TO REDUCE THE NUMBER OF DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646904 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention