BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 15813402 · Received November 17, 2022

    Report

    Report Number
    2017233-2022-03491
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    August 12, 2022
    Report Date
    November 16, 2022
    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

    THE CAUSE OF DISSECTION AND RUPTURE WAS UNKNOWN. IT WAS REPORTED THAT THE COMMON ILIAC ARTERY WAS SHORT AND STENOTIC. THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) IS INTENDED TO BE USED IN PATIENTS WITH A COMMON ILIAC OR AORTOILIAC ANEURYSM, WHO HAVE APPROPRIATE ANATOMY, INCLUDING AN ADEQUATE ILIAC / FEMORAL ACCESS. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. ACCORDING TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO ILIO-FEMORAL VESSEL DISSECTION AND RUPTURE. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. THE ARTICLE: YASUTOSHI TSUDA, ET AL. EARLY OUTCOMES OF INTERNAL ILIAC ARTERY RECONSTRUCTION IN EVAR AND INNOVATIONS TO EXPAND THE INDICATIONS. THE JAPANESE JOURNAL OF VASCULAR SURGERY. 2022: 31(SUPPL.) P.PR16-1 WAS ATTACHED TO THE REPORT 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: YASUTOSHI TSUDA, ET AL. EARLY OUTCOMES OF INTERNAL ILIAC ARTERY RECONSTRUCTION IN EVAR AND INNOVATIONS TO EXPAND THE INDICATIONS. THE JAPANESE JOURNAL OF VASCULAR SURGERY. 2022: 31(SUPPL.) P.PR16-1. THE AUTHORS INVESTIGATED EARLY OUTCOMES OF 49 PATIENTS WHO UNDERWENT INTERNAL ILIAC ARTERY (IIA) RECONSTRUCTION USING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) FROM DECEMBER 2018 TO NOVEMBER 2021 AT THE REPORTING HOSPITAL. RESULTS: 15 OF THE 49 PATIENTS UNDERWENT BILATERAL RECONSTRUCTION, THUS A TOTAL OF 64 IBES WERE IMPLANTED. 40 MEN AND 9 WOMEN WERE INCLUDED. THE MEDIAN AGE AT THE PROCEDURE WAS 77 YEARS. AS THE MAIN EVAR DEVICE, EXCLUDER WAS USED IN 27 PATIENTS AND ENDURANT WAS USED IN 21 PATIENTS. ENDURANT WAS MAINLY USED IN PATIENTS WITH HOSTILE PROXIMAL NECKS. RECONSTRUCTIVE IBES WERE PLACED AS CONVENTIONAL WAY IN 34 CASES, AND IN 11 CASES, THE IBES WERE PLACED AFTER THE MAIN DEVICE BY CROSSING OVER THE DELIVERY SHEATH. IN ADDITION, FOR ONE PATIENT EACH WITH A VERY SHORT CIA AND WITH A PROXIMAL CIA STENOSIS, THE MAIN DEVICE WAS IMPLANTED, THE DELIVERY SHEATH WAS CROSSED OVER AND THE LEG WAS DELIVERED TO THE IIA, AND KISSING TECHNIQUE WAS PERFORMED BETWEEN THE LEG INSERTED FROM THE EIA AND THE IPSILATERAL LEG INSERTED TO THE CIA, SO-CALLED "DOUBLE D TECHNIQUE" WAS PERFORMED. IN ONE CASE WITH A SUFFICIENT NECK AT THE PROXIMAL CIA, IBE DEVICE WAS IMPLANTED ALONE FOR A SINGLE CIA ANEURYSM. INITIAL PROCEDURAL SUCCESS WAS ACHIEVED IN 48 CASES (98.0%) AND 63 INTERNAL/EXTERNAL BIFURCATIONS (98.4%). INTRA-OPERATIVE ADVERSE EVENTS WERE OBSERVED IN 2 CASES (IIA RUPTURE IN 1 CASE AND IIA DISSECTION IN 1 CASE). NO POSTOPERATIVE CLAUDICATION, INTESTINAL ISCHEMIA, OR PARAPLEGIA WAS OBSERVED. THERE WAS NO INTRA-OPERATIVE DEATH, BUT 4 DEATHS WERE OBSERVED AFTER THE PROCEDURE, ALL OF WHICH WERE NOT AORTIC-RELATED. POSTOPERATIVE CONTRAST-ENHANCED CT WAS PERFORMED IN 46 PATIENTS, AND THE PATENCY RATE OF RECONSTRUCTED IIA WAS 95.1% (58/61 INTERNAL AND EXTERNAL BRANCHES) (OCCLUSION IN 3 IIAS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178372 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| O