BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 10520254 · Received September 11, 2020

    Report

    Report Number
    3013164176-2020-01040
    Event Type
    Death
    Date Received
    September 11, 2020
    Date of Event
    June 12, 2019
    Report Date
    November 11, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6-CODE 4111: REQUESTS WERE SENT TO THE AUTHOR TO PROVIDE FOR EXAMPLE THE SERIAL NUMBER OF THE DEVICE, PATIENT ID AND IMAGING SERIES. THE REQUESTS REMAINED UNANSWERED. H6-CODE 3221: WITHOUT ADDITIONAL INFORMATION GORE WAS UNABLE TO DO FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING LITERATURE WAS REVIEWED: "A PROPENSITY SCORE-MATCHED COMPARISON OF TWO COMMERCIALLY AVAILABLE ILIAC BRANCH DEVICES IN PATIENTS WITH SIMILAR CLINICAL AND ANATOMIC PREOPERATIVE FEATURES" FABRIZIO MASCIELLO ET AL. PRESENTED IN THE INTERNATIONAL FAST TALK SESSION AT THE 2019 VASCULAR ANNUAL MEETING OF THE SOCIETY FOR VASCULAR SURGERY, NATIONAL HARBOR, MD, JUNE 12-15, 2019. JOURNAL OF VASCULAR SURGERY, VOLUME 71, ISSUE 4, APRIL 2020, PAGES 1207-1214 HTTPS://DOI.ORG/10.1016/J.JVS.2019.07.058. MEAN AGE: 71 YEARS VAST MAJORITY IS MALE. (B)(4). ANOTHER REPORT RELATED TO THIS LITERATURE WAS SUBMITTED WITH REPORT NUMBER 3013164176-2020-01039, GORE REF NO. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING LITERATURE WAS REVIEWED: "A PROPENSITY SCORE-MATCHED COMPARISON OF TWO COMMERCIALLY AVAILABLE ILIAC BRANCH DEVICES IN PATIENTS WITH SIMILAR CLINICAL AND ANATOMIC PREOPERATIVE FEATURES" FABRIZIO MASCIELLO ET AL. PRESENTED IN THE INTERNATIONAL FAST TALK SESSION AT THE 2019 VASCULAR ANNUAL MEETING OF THE SOCIETY FOR VASCULAR SURGERY, NATIONAL HARBOR, MD, JUNE 12-15, 2019. JOURNAL OF VASCULAR SURGERY, VOLUME 71, ISSUE 4, APRIL 2020, PAGES 1207-1214 HTTPS://DOI.ORG/10.1016/J.JVS.2019.07.058. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE PERIOPERATIVE AND MIDTERM RESULTS OF COOK MEDICAL ZENITH® BRANCH ENDOVASCULAR GRAFT- ILIAC BIFURCATION (ZBIS DEVICE) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE) IN TREATMENT OF DILATED ILIAC BIFURCATIONS DUE TO AORTOILIAC ANEURYSMS. THE IBE DEVICE CONSISTS OF TWO COMPONENTS: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT (CEB DEVICE) AND INTERNAL ILIAC COMPONENT (HGB DEVICE) BETWEEN JULY 2007 AND MAY 2018, 190 ILIAC BRANCH DEVICES (IBD) WERE IMPLANTED AT TWO CENTERS. AMONG THE SERIES, TWO PREOPERATIVE PROPENSITY SCORE MATCHING GROUPS WERE CREATED: GROUP 1: 35 COOK ZBIS DEVICES, USED SINCE (B)(6) 2007. GROUP 2: 35 GORE IBE DEVICES, USED SINCE (B)(6) 2013. BOTH, ZBIS AND IBE DEVICES, FEATURE A SIMILAR IMPLANTATION TECHNIQUE, WITH A FLOPPY GUIDEWIRE PLACED THROUGH BILATERAL FEMORAL ACCESSES TO STABILIZE THE DEVICE DURING IMPLANTATION AND TO PROVIDE SUPPORT TO THE 12F FLEXIBLE HYDROPHILIC SHEATH PLACED IN A CROSSOVER FASHION INTO THE SIDE BRANCH FOR INTERNAL ILIAC ARTERY (IIA) TO DELIVER THE BRIDGING STENT IN THE TARGET IIA. IN CASE OF EXCLUSION OF AN ILIAC ANEURYSMAL DEGENERATION DISTAL TO A PREVIOUS OPEN OR ENDOVASCULAR AORTOILIAC BIFURCATED REPAIR, A BRACHIAL APPROACH WAS USED. THE FOLLOWING ADDITIONAL MEDICAL DEVICES WERE MENTIONED WITHIN THE LITERATURE: GROUP 1: AN ATRIUM ADVANTA V12 (GETINGE) WAS USED AS A BRIDGING STENT IN 33 CASES. THE TWO REMAINING IMPLANTATIONS WERE COMPLETED WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN DEVICE) IN ONE PATIENT AND A FLUENCY¿ PLUS ENDOVASCULAR STENT GRAFT (BARD) IN THE OTHER PATIENT TO LAND DISTALLY IN THE GLUTEAL ARTERY. GROUP 2: ALL BUT ONE PATIENT RECEIVED DEDICATED CEB AND HGB COMPONENTS, IN TWO CASES COMBINED WITH AN ADDITIONAL NITINOL SELF-EXPANDING STENT: ONE ABSOLUTE PRO® VASCULAR SELF-EXPANDING STENT SYSTEM (ABBOTT) TO STRAIGHTEN A SEVERELY KINKED HGB COMPONENT, AND ONE VIABAHN DEVICE FOR DISTAL EXTENSION IN A GLUTEAL ARTERY BECAUSE OF THE LACK OF DISTAL LANDING ZONE IN AN ANEURYSMAL IIA. ONE IMPLANTATION WAS COMPLETED USING A VIABAHN DEVICE AS THE BRIDGING STENT GRAFT. THE FOLLOWING POST-OPERATIVE EVENT WAS REPORTED WITHIN THE LITERATURE: ONE TYPE IB ENDOLEAK FROM THE TARGET IIA WAS DIAGNOSED IN ONE PATIENT AND WAS TREATED TWO MONTHS AFTER THE INDEX PROCEDURE BY RELINING THE BRIDGING STENT GRAFT. IT REMAINS UNCLEAR IF A VIABAHN OR AN HGB DEVICE WAS USED IN THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984856 GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization