BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 9333838 · Received November 18, 2019

    Report

    Report Number
    2017233-2019-01153
    Event Type
    Death
    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

    THE SERIAL NUMBERS FOR THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WERE NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. H6: 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: ENDOLEAK, DEATH.

    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 1.4 YEARS POST IMPLANT, THERE WAS ONE FATAL AORTIC RUPTURE WITH A KNOWN TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133756 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Death