BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20504742 · Received October 22, 2024

    Report

    Report Number
    3007284313-2024-03530
    Event Type
    Death
    Date Received
    October 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    December 17, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED H6: UPDATED COMPONENT CODE TO G07001. CODE G07003 WAS INADVERTENTLY ENTERED AND SHOULD BE REMOVED.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A2: MEAN AGE OF 72.1 YEARS WAS STATED IN THE ARTICLE. A3: PREDOMINANTLY MALE PATIENTS WAS STATED IN THE ARTICLE. B3: THE EXACT DATE OF EVENT IS UNKNOWN, THEREFORE, THE DATE OF WHICH THE EXPLANT TOOK PLACE WAS USED AS DATE OF EVENT. H3: OTHER CODE ¿ THE MEDICAL DEVICES ARE NOT RETURNED FOR INVESTIGATION, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. LITERATURE CITATION: SMORENBURG, S. P. M., DE BRUIN, J. L. ZEEBREGTS, C. J., REIJNEN, M. M. P. J., VERHAGEN, H. J. M., AND HEYLIGERS, J. M. M. (2024) ¿LONG TERM OUTCOMES OF THE GORE EXCLUDER LOW PERMEABILITY ENDOPROSTHESIS FOR THE TREATMENT OF INFRARENAL AORTIC ANEURYSMS,¿ EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 68(1), PP. 18¿27. DOI: 10.1016/J.EJVS.2024.03.028. NO PATIENT SPECIFIC INFORMATION REGARDING THE REPORTED EVENTS AND INTERVENTIONS WAS PROVIDED IN THE ARTICLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. GORE REACHED OUT MULTIPLE TIMES TO THE AUTHOR OF THE LITERATURE ARTICLE FOR DEVICE IDENTIFICATION LINKED WITH THE REPORTED OUTCOME. THE ANSWER IS NOT PROVIDED. 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 ANEURYSM RUPTURE AND DEATH. 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 ARTICLE WAS REVIEWED: SMORENBURG, S. P. M., DE BRUIN, J. L. ZEEBREGTS, C. J., REIJNEN, M. M. P. J., VERHAGEN, H. J. M., AND HEYLIGERS, J. M. M. (2024) ¿LONG TERM OUTCOMES OF THE GORE EXCLUDER LOW PERMEABILITY ENDOPROSTHESIS FOR THE TREATMENT OF INFRARENAL AORTIC ANEURYSMS,¿ EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 68(1), PP. 18¿27. DOI: 10.1016/J.EJVS.2024.03.028. THIS RETROSPECTIVE, MULTI-CENTER STUDY EVALUATED LONG-TERM OUTCOMES OF 514 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 72.1 YEARS WHO WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) BETWEEN JUNE 2004 AND JANUARY 2017. PRIMARY OUTCOMES WERE OVERALL SURVIVAL, FREEDOM FROM REINTERVENTIONS, AAA SAC DYNAMICS: GROWTH (> 5 MM), STABILIZATION, AND REGRESSION (< 5 MM). SECONDARY OUTCOMES WERE TECHNICAL SUCCESS (DEVICE DEPLOYMENT), PROCEDURAL PARAMETERS, AND REINTERVENTIONS. 195 PATIENTS WERE REPORTED AS BEING TREATED OUTSIDE INSTRUCTIONS FOR USE (IFU). TREATMENT OUTSIDE IFU SIGNIFICANTLY INCREASED REINTERVENTION RATES AND ONE YEAR SAC GROWTH WAS ASSOCIATED WITH STATISTICALLY SIGNIFICANTLY WORSE SURVIVAL. DURING FOLLOW UP, THE AAA OF SEVEN PATIENTS RUPTURED: ONE WAS IDENTIFIED AS A TYPE 3 ENDOLEAK, ANOTHER WAS DUE TO A TYPE 1A ENDOLEAK, AND THE THIRD WAS CAUSED BY A TYPE 1B ENDOLEAK; THE REMAINING CAUSES FOR THE OTHER FOUR CASES REMAINED UNDETERMINED DUE TO NON-AVAILABILITY OF RELEVANT INFORMATION IN THE RETROSPECTIVE DOCUMENTATION. FOUR OF THE PATIENT UNDERWENT CONVERSION AND/OR LIMB EXTENSION (PLEASE SEE MANUFACTURER'S REFERENCE NUMBER (B)(4)), THREE PATIENTS DIED. THE EXACT CAUSE OF THE RUPTURE OR REMEDIAL ACTION OF THESE THREE DECEASED PATIENTS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029474 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death