BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17865525 · Received October 3, 2023

    Report

    Report Number
    3007284313-2023-02798
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    September 1, 2023
    Report Date
    October 27, 2023
    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

    DEVICE WAS DISCARDED. AN IMAGE OF EXPLANTED DEVICE WAS PROVIDED. IMAGING ANALYSIS WAS PERFORMED, AND THE FOLLOWING WAS REPORTED: TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION HOWEVER, THE SPECIMENS WERE NOT RETURNED TO W. L. GORE & ASSOCIATES. THE VISIBLE ABLUMEN OF THE SPECIMENS APPEARED RED IN COLOR WITH SMALL AMOUNTS OF PRESUMED BIOLOGIC TISSUE. THE LUMEN OF THE PRESUMED CONTRALATERAL GATE APPEARED WIDELY PATENT, WHILE THE LUMEN OF THE PRESUMED IPSILATERAL LEG APPEARED TO BE OCCLUDED WITH DARK RED TO BLACK BIOLOGIC MATERIAL. THE LUMEN OF THE DISTAL END OF THE PRESUMED IPSILATERAL LEG APPEARED TO BE LARGELY OCCUPIED WITH LIGHT TAN TO YELLOW SMOOTH BIOLOGIC MATERIAL. THE GROSS APPEARANCE OF THE LUMINAL MATERIAL WAS CONSISTENT WITH THE CLINICAL ASSESSMENT OF ¿WHITE BLOOD CLOT¿ (I.E., PLATELET RICH THROMBUS). A DEFINITIVE ASSESSMENT OF THE NATURE OF THE BIOLOGIC MATERIAL AND PATENCY COULD NOT BE DETERMINED BASED ON THE PHOTOGRAPHS PROVIDED.

    Additional Manufacturer Narrative · 0

    AS THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE, SEVERAL DEVICES WERE EXPLANTED. THE FOLLOWING EXPLANTED DEVICES WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG #CEB231010A/ SERIAL #: (B)(6)/ UDI #: (B)(4). CATALOG #PLC271200J/ SERIAL #: (B)(6)/ UDI #: (B)(4). H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE C20-THE DEVICE WAS DISCARDED AND, THEREFORE, WAS NOT AVAILABLE FOR ENGINEERING ANALYSIS BY GORE. IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, OCCLUSION OF DEVICE OR NATIVE VESSEL 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.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). DURING THE PROCEDURE, A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT281218J) WAS PLACED ON THE RIGHT SIDE. A SET OF IBE DEVICES WERE PLACED ON THE LEFT ILIAC ARTERIES (CEB231010A+HGB161007A) WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC271200J) AS A BRIDGING DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE OF (B)(6) 2023, THE IPSILATERAL LEG OF THE RLT281218J ON THE RIGHT SIDE WAS FOUND TO BE THROMBOSED AND COMPLETELY OCCLUDED. THE PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED TO TREAT THE RIGHT LEG OCCLUSION. THE INITIAL PLAN WAS TO USE A FOGARTY® ARTERIAL EMBOLECTOMY CATHETER TO REMOVE THE THROMBUS AND EXTEND THE IPSILATERAL LEG WITH AN ADDITIONAL STENT GRAFT. THE RIGHT FEMORAL ARTERY WAS CUT DOWN FROM WHICH A GUIDE WIRE WAS ADVANCED. REPORTEDLY, THE GUIDE WIRE WAS UNABLE TO ADVANCE THROUGH THE OCCLUDED IPSILATERAL LEG OF THE RLT281218J. SEVERAL ATTEMPTS WERE MADE BY USING VARIOUS WIRES INCLUDING A RADIFOCUS® GUIDEWIRE (TERUMO CORPORATION), A HALBERD (ASAHI INTECC CO., LTD) AND A CHEVALIER (NIPRO CORPORATION), HOWEVER, NONE OF THEM WERE ABLE TO ADVANCE THROUGH THE IMPLANTED RLT281218J. IT WAS DECIDED TO CONVERT TO AN OPEN SURGERY AND REPLACE THE IMPLANTED STENT GRAFTS WITH A Y-SHAPED VASCULAR GRAFT. THE RLT281218J ON THE RIGHT SIDE, THE BRIDGING PLC271200J AND THE TRUNK PORTION OF THE CEB231010A ON THE LEFT SIDE WERE EXPLANTED. A Y-SHAPED VASCULAR GRAFT WAS THEN SEWN AS A REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE WHITE BLOOD CLOT WAS NOTED WITHIN THE EXPLANTED IPSILATERAL LEG OF THE RLT281218J. ACCORDING TO THE REPORTING PHYSICIAN, THE DISTAL EDGE OF THE IPSILATERAL LEG OF THE RLT281218J WAS LOCATED AT THE TORTUOUS NATIVE VESSEL, WHICH MIGHT HAVE DISTURBED THE BLOOD FLOW AND CONTRIBUTED TO THE THROMBOTIC OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589743 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention