BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 21708365 · Received March 27, 2025

    Report

    Report Number
    3007284313-2025-03858
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    October 26, 2024
    Report Date
    March 27, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: THE MEAN AGE AMONG THE PATIENTS WAS REPORTED TO 74 YEARS. B3: THE DATE OF EVENT IS UNKNOWN. THEREFORE, THE ONLINE PUBLICATION DATE OF THE LITERATURE ARTICLE IS USED AS DATE OF EVENT. D10: CONCOMITANT MEDICAL PRODUCTS: (RELEVANT ASSOCIATED DEVICES USED WITH THE DEVICE BEING REPORTED ON): GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS OR GORE® VIABAHN® ENDOPROSTHESIS. GORE ATTEMPTED TO ACQUIRE ADDITIONAL INFORMATION TO CLASSIFY A SPECIFIC DEVICE PROBLEM, DEVICE IDENTIFICATION, AND PATIENT DETAILS. THE CORRESPONDING AUTHOR WAS NOT ABLE TO PROVIDE ANY FURTHER DATA AS IT WAS STATED THAT THE STUDY WAS PURELY RETROSPECTIVE. NO MALFUNCTIONS OF DEVICES WERE RECEIVED FROM THE INVESTIGATORS INVOLVED IN THIS STUDY. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED/REMAINED IMPLANTED. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. THIS COMPLAINT WAS INITIATED BASED ON A REVIEWED LITERATURE ARTICLE, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. PER THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK, OCCLUSION OF DEVICE OR NATIVE VESSEL. LITERATURE CITATION: D¿ORIA, M., PITOULIAS, G., LEPIDI, S., BELLOSTA, R., REIJNEN, M.M.P.J., SIMONTE, G., PRATESI, G. USAI, M.V., GARGIULO, M., DIAS, N., FERRER, C., BENEDETTO, F., VERALDI, G.F., DUPPERS, P., NOYA, J.F., WIERSEMA, A., SPANOS, K., TROISI, N., MONIACI, D., ANTONELLO, M., TRIMARCHI, S., DE VRIES. J.-P., ABISI, S., PITOULIAS, A., TANEVA, G.T. AND DONAS, K.P. ON BEHALF OF THE HYPROTECT STUDY. (2024). MID-TERM OUTCOMES OF THE ILIAC BRANCH ENDOPROSTHESIS WITH STANDARDIZED COMBINATIONS OF BRIDGING STENT-GRAFTS FOR ENDOVASCULAR TREATMENT OF AORTOILIAC DISEASE WITH OR WITHOUT CO-EXISTING HYPOGASTRIC ANEURYSMS (THE HYPROTECT STUDY). CARDIOVASC INTERV RADIOL. 47(12), PP. 1739-1749. DOI:10.1007/S00270-024-03881-Z. 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: D¿ORIA, M., PITOULIAS, G., LEPIDI, S., BELLOSTA, R., REIJNEN, M.M.P.J., SIMONTE, G., PRATESI, G. USAI, M.V., GARGIULO, M., DIAS, N., FERRER, C., BENEDETTO, F., VERALDI, G.F., DUPPERS, P., NOYA, J.F., WIERSEMA, A., SPANOS, K., TROISI, N., MONIACI, D., ANTONELLO, M., TRIMARCHI, S., DE VRIES. J.-P., ABISI, S., PITOULIAS, A., TANEVA, G.T. AND DONAS, K.P. ON BEHALF OF THE HYPROTECT STUDY. (2024). MID-TERM OUTCOMES OF THE ILIAC BRANCH ENDOPROSTHESIS WITH STANDARDIZED COMBINATIONS OF BRIDGING STENT-GRAFTS FOR ENDOVASCULAR TREATMENT OF AORTOILIAC DISEASE WITH OR WITHOUT CO-EXISTING HYPOGASTRIC ANEURYSMS (THE HYPROTECT STUDY). CARDIOVASC INTERV RADIOL. 47(12), PP. 1739-1749. DOI:10.1007/S00270-024-03881-Z. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE 2-YEAR OUTCOMES OF PATIENTS THAT UNDERWENT EVAR FOR TREATMENT OF COMMON ILIAC ARTERY WHO RECEIVED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS [IBE] AND A BRIDGING DEVICE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS OR GORE® VIABAHN® ENDOPROSTHESIS WITH AND WITHOUT COEXISTING HYPOGASTRIC ARTERY [HA] ANEURYSMS BETWEEN 2016 AND 2022. A TOTAL OF 437 PATIENTS [MEAN AGE 74] FROM 22 EUROPEAN VASCULAR SURGERY CENTERS WERE INCLUDED AND BROKEN UP INTO TWO GROUPS. GROUP A DID NOT HAVE HA ANEURYSMS AND GROUP B DID HAVE HA. A TOTAL OF 515 IBE DEVICES WERE IMPLANTED AS 78 PATIENTS HAD BILATERAL IBES. TECHNICAL SUCCESS WAS ACHIEVED IN 421 PATIENTS. FOLLOW UP TIME FOR THE ENTIRE STUDY WAS 19.8-36.5 MONTHS. COMPLICATIONS INCLUDED OCCLUSION OF THE HA (6 PATIENTS), INTRAOPERATIVE ENDOLEAK I OR III (10 PATIENTS), SPONTANEOUS SEAL AT 30-DAY (7 PATIENTS), 30-DAY IBE RELATED ENDOLEAK [TYPE IB AND III] (15 AND 9 PATIENTS RESPECTIVELY), 30-DAY REINTERVENTIONS INCLUDE AORTIC RELATED, DEVICE RELATED AND OTHER REASONS (4, 3, AND 5 PATIENTS RESPECTIVELY). ALL 12 REINTERVENTIONS WERE SUCCESSFUL. THE AUTHORS CONCLUDED THAT THE FINDINGS OF THIS STUDY SUPPORT THE APPLICATION OF IBE IN PATIENTS WITH HYPOGASTRIC ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438564 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Other SEE H10.