BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE)

    MDR report key: 9333809 · Received November 18, 2019

    Report

    Report Number
    2017233-2019-01152
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 21, 2019
    Report Date
    December 28, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT G4. DATE RECEIVED BY MANUFACTURER, THAT WAS PROVIDED IN THE FOLLOW-UP #1 REPORT SENT NOVEMBER 18, 2019.

    Additional Manufacturer Narrative · 0

    B5: ADDED INFORMATION.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CODES WERE CORRECTED: PATIENT CODE 1, DEVICE CODE 1, METHOD CODE 1, RESULTS CODE 1. THE FOLLOWING CODES WERE ADDED: METHOD CODE 2, CONCLUSION CODES 1 AND 2. THE SERIAL NUMBERS FOR THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WERE NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. CODE 22 - ACCORDING TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGMENT, ENDOLEAK.

    Description of Event or Problem · 0

    OF THOSE 26 PATIENTS, 6 SHOWED ANEURYSM INCREASES EXCEEDING 5 MM.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: "ERFAHRUNGEN UND ERGEBNISSE MIT DER ENDOVASKULÄREN BEHANDLUNG VON (AORTO-)ILIACALEN ANEURYSMEN MIT ILIAC BRANCH ENDOGRAFT (IBE)" [ENGLISH TRANSLATION: "EXPERIENCES AND RESULTS: ENDOVASCULAR TREATMENT OF (AORTO-) ILIAC ANEURYSMS WITH ILIAC BRANCH ENDOGRAFTS (IBE)"]; POSTER PRESENTATION AT THE 35TH ANNUAL SCIENTIFIC CONFERENCE OF THE DGG, DEUTSCHE GESELLSCHAFT FÜR GEFÄSSCHIRURGIE UND GEFÄSSMEDIZIN (GERMAN SOCIETY FOR VASCULAR SURGERY AND VASCULAR MEDICINE); OCTOBER 16 TO 19, 2019, MANNHEIM (GERMANY). AUTHORS: O. STANGER, S. LACHER, C. SCHÖN, S.SCHÖNHOFER, R. MANSOUR, E.HEYZL, J. HUDJETZ, T.KUBINKE, R.GOTHBI; HELIOS KLINIKUM MÜNCHEN WEST (PASING), AORTENZENTRUM SÜD. PURPOSE: THE POSTER REPORTED ON TECHNICAL AND CLINICAL EXPERIENCES WITH IMPLANTS INVOLVING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. METHODS: 62 MALE PATIENTS WITH A MEAN AGE OF 77.7 YEARS WERE TREATED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (UNI-ILIAC: N=54; BI-ILIAC: N=8) BETWEEN SEPTEMBER 2013 AND SEPTEMBER 2019. TREATED INDICATIONS WERE ABDOMINAL AORTIC ANEURYSM/COMMON ILIAC ARTERY ANEURYSM: 38 PATIENTS; COMMON ILIAC ARTERY ANEURYSM ONLY: 17 PATIENTS; INTERNAL ILIAC ARTERY ANEURYSM ONLY: 3 PATIENTS; COMMON ILIAC ARTERY ANEURYSM/INTERNAL ILIAC ARTERY ANEURYSM: 4 PATIENTS. RESULTS: RETROSPECTIVE DATA ANALYSIS REVEALED THAT TECHNICAL SUCCESS (24 HOURS) AND CLINICAL IMPLANTATION SUCCESS (30 DAYS) WAS 93.5 % EACH. THERE WAS NO 30 DAY (IN-HOSPITAL) MORTALITY. CUMULATED 130.7 PATIENT YEARS SHOW NOW CASE OF PROSTHESIS INFECTION, LATE OCCLUSION, STENT MIGRATION OR LOSS OF STENT INTEGRITY. THE INFORMATION ON THE POSTER REPORTED THAT 26 PATIENTS (41.9%) HAD AN EARLY TYPE II ENDOLEAK, WITH 20 STATIONARY OR REGRESSIVE ANEURYSM DIAMETERS. UP TO NOW, 8 REINTERVENTIONS HAD TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133885 AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R