BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21280953 · Received January 31, 2025

    Report

    Report Number
    3007284313-2025-03733
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    October 19, 2024
    Report Date
    January 31, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P20004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: A CASE OF URGENT ENDOANEURYSMORRAPHY FOR AN IMPENDING RUPTURE OF AN INFLAMMATORY AORTIC ANEURYSM THAT DEVELOPED AFTER EVAR AT ANOTHER HOSPITAL. SOURCE: THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY (0387-1126)64, SUPPL. PAGE S185. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ENDOLEAK, ANEURYSM ENLARGEMENT 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 PUBLICATION WAS REVIEWED: TITLE: A CASE OF URGENT ENDOANEURYSMORRAPHY FOR AN IMPENDING RUPTURE OF AN INFLAMMATORY AORTIC ANEURYSM THAT DEVELOPED AFTER EVAR AT ANOTHER HOSPITAL. SOURCE: THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY (0387-1126)64, SUPPL. PAGE S185. A (B)(6) YEAR-OLD MALE. THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT SIX YEARS AGO IN ANOTHER HOSPITAL FOR AN IMPENDING RUPTURE OF ABDOMINAL AORTIC ANEURYSM (64 MM), GORE® EXCLUDER®AAA ENDOPROSTHESES WERE IMPLANTED WITH THE SNORKEL TECHNIQUE FOR BILATERAL RENAL ARTERIES. POSTOPERATIVELY THE ANEURYSM SIZE HAD ENLARGED, AND AS A TREATMENT CT-GUIDED EMBOLIZATION FOR THE INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY WAS PERFORMED 4 YEARS AGO. HOWEVER, THE ANEURYSM SIZE HAD EXPANDED TO 76 MM. THIS TIME, THE PATIENT WAS TRANSFERRED TO OUR FACILITY WITH A COMPLAINT OF ABDOMINAL PAIN AND WAS DIAGNOSED AS AN IMPENDING RUPTURE OF ABDOMINAL AORTIC ANEURYSM. THE PATIENT UNDERWENT AN URGENT ENDOANEURYSMORRAPHY. A VENTRAL MIDLINE CELIOTOMY AND A RETROPERITONEAL APPROACH WAS MADE. WHEN THE ABDOMINAL AORTIC ANEURYSM WAS EXPOSED, NO HEMATOMA WAS FOUND IN THE RETROPERITONEUM. THE ANEURYSM WALL LOOKED WHITE AND CERAMIC-LIKE, SUGGESTING AN INFLAMMATORY ANEURYSM. THERE WERE NO TYPE I NOR TYPE III ENDOLEAKS OBSERVED, WHILE A TYPE II ENDOLEAKS SUCH AS THE LUMBAR ARTERIES WERE CONFIRMED. IT WAS SUTURED TO TREAT THE BLEEDING. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED 15 DAYS AFTER THE SURGERY. THE PHYSICIAN MENTIONED THAT THE ANEURYSM HAD ENLARGED BECAUSE IT WAS ORIGINALLY AN INFLAMMATORY ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520296 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention