BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 19257509 · Received May 7, 2024

    Report

    Report Number
    3007284313-2024-03210
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    July 23, 2023
    Report Date
    October 31, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INITIATED BASED ON A REVIEWED LITERATURE ARTICLE. CLINICAL IMAGES, ADDITIONAL PATIENT DETAILS INCLUDING REASONS FOR CONVERSION TO OPEN SURGERY WERE REQUESTED FOR EVALUATION. THE REQUESTED INFORMATION WAS NOT PROVIDED. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR EXPLANTED PRODUCTS WERE RETURNED FOR EVALUATION. THEREFORE, THE CAUSE OF THE CONVERSION TO OPEN SURGERY COULD NOT BE INDEPENDENTLY CONFIRMED DURING THE INVESTIGATION. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO SURGICAL CONVERSION. FOR THE PURPOSES OF REPORTING, THE DATE OF PUBLICATION WAS USED AS THE EVENT DATE IN SECTION 4.3.3 INDIVIDUAL PATIENT INFORMATION WAS NOT PROVIDED. THE PREDOMINANT GENDER AND AVERAGE AGE HAS BEEN USED INSTEAD.

    Additional Manufacturer Narrative · 0

    THE DISPOSITION OF ANY EXPLANTED DEVICES IS UNKNOWN. THE AUTHOR HAS BEEN CONTACTED AND ASKED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE COMPLAINT, INCLUDING IMAGING SERIES IF AVAILABLE. THEREFORE, IMAGING EVALUATIONS COULD NOT BE PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE CITATION: ESPADA, C.L., BEHRENDT, C.A., MANI, K., D¿ORIA, M., LATTMAN, T., KHASHRAM, M., ALTREUTHER, M., COHNERT, T.U., PHERWANI, A., BUDTZ-LILLY, J. AND LINARES-PALOMINO, J., 2024. THE VASCUNEXPLANT PROJECT: AN INTERNATIONAL STUDY ASSESSING OPEN SURGICAL CONVERSION OF FAILED NON-INFECTED ENDOVASCULAR AORTIC ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY, 79(1), P.181. HTTPS://DOI.ORG/10.1016/J.JVS.2023.10.010.

    Description of Event or Problem · 0

    THE BELOW LITERATURE ARTICLE WAS REVIEWED: ESPADA, C.L., BEHRENDT, C.A., MANI, K., D¿ORIA, M., LATTMAN, T., KHASHRAM, M., ALTREUTHER, M., COHNERT, T.U., PHERWANI, A., BUDTZ-LILLY, J. AND LINARES-PALOMINO, J., 2024. THE VASCUNEXPLANT PROJECT: AN INTERNATIONAL STUDY ASSESSING OPEN SURGICAL CONVERSION OF FAILED NON-INFECTED ENDOVASCULAR AORTIC ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY, 79(1), P.181. HTTPS://DOI.ORG/10.1016/J.JVS.2023.10.010 THE ARTICLE IS A RETROSPECTIVE CROSS SECTIONAL STUDY OF PATIENTS TREATED WITH OPEN SURGERY FOLLOWING ENDOVASCULAR AORTIC REPAIR. THREE HUNDRED FORTY-EIGHT PATIENTS FROM 55 CENTERS WERE ENROLLED. ELEVEN PATIENTS WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. PATIENT OUTCOMES ARE NOT BROKEN DOWN BY DEVICE.

    Description of Event or Problem · 0

    THE BELOW LITERATURE ARTICLE WAS REVIEWED: ESPADA, C.L., BEHRENDT, C.A., MANI, K., D¿ORIA, M., LATTMAN, T., KHASHRAM, M., ALTREUTHER, M., COHNERT, T.U., PHERWANI, A., BUDTZ-LILLY, J. AND LINARES-PALOMINO, J., 2024. THE VASCUNEXPLANT PROJECT: AN INTERNATIONAL STUDY ASSESSING OPEN SURGICAL CONVERSION OF FAILED NON-INFECTED ENDOVASCULAR AORTIC ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY, 79(1), P.181. HTTPS://DOI.ORG/10.1016/J.JVS.2023.10.010. THE ARTICLE IS A RETROSPECTIVE CROSS SECTIONAL STUDY OF PATIENTS TREATED WITH OPEN SURGERY FOLLOWING ENDOVASCULAR AORTIC REPAIR. THREE HUNDRED FORTY-EIGHT PATIENTS FROM 55 CENTERS WERE ENROLLED. THIRTY-NINE PATIENTS WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. PATIENT OUTCOMES ARE NOT BROKEN DOWN BY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380896 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other