BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 25169416 · Received May 14, 2026

    Report

    Report Number
    3007284313-2026-04773
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    February 13, 2026
    Report Date
    May 14, 2026
    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

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. LITERATURE TITLE: WALL DERIVED ATYPICAL TYPE II ENDOLEAK 10 YEARS AFTER ENDOVASCULAR ANEURYSM REPAIR: INTRA-OPERATIVE AND HISTOPATHOLOGICAL EVIDENCE OF VASA VASORUM MEDIATED HAEMORRHAGE SOURCE: EJVES VASCULAR FORUM (2026) 65, 127 - 130. 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 LITERATURE WAS REVIEWED. TITLE: WALL DERIVED ATYPICAL TYPE II ENDOLEAK 10 YEARS AFTER ENDOVASCULAR ANEURYSM REPAIR: INTRA-OPERATIVE AND HISTOPATHOLOGICAL EVIDENCE OF VASA VASORUM MEDIATED HAEMORRHAGE AUTHORS: YUSUKE KINUGASA, ET AL. SOURCE: EJVES VASCULAR FORUM (2026) 65, 127 - 130. A 76-YEAR-OLD MAN UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING AN EXPANDED POLYTETRAFLUOROETHYLENE ENDOGRAFT (GORE® EXCLUDER® AAA ENDOPROSTHESIS) FOR A 57 × 68 MM INFRARENAL ABDOMINAL AORTIC ANEURYSM 10 YEARS EARLIER. AT THE INDEX PROCEDURE, COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY AND THE RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED. THE EARLY POSTOPERATIVE COURSE WAS UNEVENTFUL; HOWEVER, AT FIVE YEARS A RECURRENT INFERIOR MESENTERIC ARTERY RELATED TYPE II ENDOLEAK WAS DETECTED AND TREATED WITH ADDITIONAL COIL EMBOLIZATION. DURING SUBSEQUENT SURVEILLANCE, THE ANEURYSM SAC PROGRESSIVELY ENLARGED FROM 59 × 71 MM TO 65 × 86 MM. PRE-CONVERSION COMPUTED TOMOGRAPHY ANGIOGRAPHY DEMONSTRATED NO PATENT INFERIOR MESENTERIC OR LUMBAR ARTERIES AND NO EVIDENCE OF TYPE I OR TYPE III ENDOLEAK, BUT DELAYED PHASE IMAGES REVEALED PATCHY ENHANCEMENT OF THE MURAL THROMBUS, RAISING SUSPICION OF A WALL DERIVED ATYPICAL TYPE II ENDOLEAK. OPEN SURGICAL CONVERSION WITH SACOTOMY REVEALED MULTIPLE SITES OF DIFFUSE OOZING FROM THE LUMINAL SURFACE OF THE ANEURYSM WALL WITHOUT BRANCH INFLOW OR ENDOGRAFT ATTACHMENT SITE BLEEDING. AFTER EXCISION OF THE ANTERIOR ANEURYSM WALL, SELECTIVE OVERSEWING OF THE OOZING POINTS WAS PERFORMED, THE ANTERIOR DEFECT WAS COVERED WITH AN EXPANDED POLYTETRAFLUOROETHYLENE PATCH, AND THE ENDOGRAFT WAS PRESERVED. HISTOPATHOLOGICAL EXAMINATION DEMONSTRATED EXTENSIVE INTIMAL DENUDATION, MEDIA EXPOSURE WITH ADVENTITIAL VASA VASORUM PROLIFERATION, AND LUMINALLY ORIENTED MICROVESSELS, CONSISTENT WITH A DIAGNOSIS OF WALL DERIVED ATYPICAL TYPE II ENDOLEAK. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY AT THREE YEARS SHOWED SUSTAINED SAC REDUCTION WITHOUT RESIDUAL ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139886 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1