BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 18919744 · Received March 18, 2024

    Report

    Report Number
    3013164176-2024-02016
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    March 6, 2024
    Report Date
    July 12, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: LOCATION OF DEVICE IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE EVALUATION OF THE RETURNED DEVICES SHOWED THE FOLLOWING: THE LEADING END OF THE CATHETER (POLYIMIDE GUIDEWIRE LUMEN AND LEADING OLIVE) HAD SEPARATED FROM THE REST OF THE CATHETER AT THE TRAILING OLIVE. THE LEADING END OF THE CATHETER WAS RETURNED WITH A GUIDEWIRE INSERTED THROUGH THE GUIDEWIRE LUMEN. DURING THE EVALUATION, THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE LEADING END OF THE CATHETER. THE TRAILING OLIVE END WAS INTACT AND NOT RIPPED OR TORN. THE INSIDE OF THE TRAILING OLIVE HAD EVIDENCE OF INDENTATIONS FROM THE POLYIMIDE GUIDEWIRE LUMEN BRAID. THE INDENTATIONS INDICATE THAT THE POLYIMIDE GUIDEWIRE LUMEN SECTION OF THE CATHETER LEADING END HAD BEEN BONDED AT THE TRAILING OLIVE. THE DEPLOYMENT KNOB REMAINED SCREWED ON THE CATHETER HUB AND THE DEPLOYMENT LINE REMAINED THREADED THROUGH THE CATHETER AND EXITED THE CATHETER TRAILING OLIVE DEPLOYMENT LINE HOLE. DURING THE DEPLOYMENT PROCESS, THE DEPLOYMENT LINE SHOULD BE PULLED THROUGH THE CATHETER BY THE DEPLOYMENT KNOB TO OPEN THE SLEEVE CONSTRAINING THE ENDOPROSTHESIS. THE END OF THE DEPLOYMENT LINE WAS CLEANLY CUT. THE CLEAN CUT INDICATES THAT THE DEPLOYMENT LINE DID NOT BREAK, AND THE DEPLOYMENT LINE WAS INTACT THROUGH THE TRIMMED TAIL OF THE LINE AS EXPECTED IN THE MANUFACTURING PROCESS. THE FINDINGS FROM THE EVALUATION ARE CONSISTENT WITH THE REPORTED OBSERVATIONS OF THE CATHETER LEADING END BEING SEPARATED FROM THE CATHETER SHAFT AT THE TRAILING OLIVE AND STUCK ON THE GUIDEWIRE. THE CAUSE FOR THE CATHETER LEADING END SEPARATION AT THE TRAILING OLIVE OR BEING STUCK ON THE GUIDEWIRE COULD NOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. ACCORDING TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE USER SHOULD NOT CONTINUE ADVANCING OR WITHDRAWING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE GUIDEWIRE, SHEATH, OR CATHETER. THE USER SHOULD STOP AND ASSESS THE CAUSE OF RESISTANCE. FORCIBLY WITHDRAWING THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH WHEN RESISTANCE IS ENCOUNTERED HAS RESULTED IN ADVERSE EVENTS INCLUDING CATHETER BREAKAGE OR SEPARATION AND REINTERVENTION RESULTING IN POTENTIAL PATIENT HARMS. 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 IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; UNINTENTIONAL/PREMATURE COMPONENT DEPLOYMENT; LEADING END CATHETER COMPONENT RETENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT PRESENTING WITH A COMMON ILIAC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE DEVICE BECAME STUCK ON THE STIFF WIRE. THE TIP OF THE CATHETER TORE OFF AND GOT STUCK ON THE WIRE. IT WAS POSSIBLE TO REMOVE THE WIRE WITH THE TIP ATTACHED WITHOUT AFFECTING THE INTERNAL ILIAC COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT PRESENTING WITH A COMMON ILIAC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. SOME RESISTANCE WAS REPORTED WHILE ADVANCING THE CATHETER OVER THE GUIDEWIRE OR THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. IT IS POSSIBLE THAT THE GUIDEWIRE WAS DAMAGED. THE INTERNAL ILIAC COMPONENT DID NOT REACH THE TARGET ANATOMY DURING THE ADVANCEMENT OF THE DELIVERY CATHETER BEFORE GETTING STUCK. THE DELIVERY CATHETER AND CONSTRAINED ENDOPROSTHESIS COULD NOT BE ADVANCED OR RETRACTED. THE ENDOPROSTHESIS WAS DEPLOYED BY PULLING ON THE CATHETER DELIVERY SYSTEM. THE DEPLOYMENT KNOB WAS NOT USED IN DEPLOYMENT. A LOT OF RESISTANCE WAS REPORTED WHILE REMOVING THE CATHETER. THE GUIDEWIRE AND DELIVERY CATHETER WERE REMOVED AT THE SAME TIME. THE SEPARATION OF THE LEADING END OF THE CATHETER WAS OBSERVED AT THIS STAGE. AFTER DEPLOYMENT, THE INTERNAL ILIAC COMPONENT REMAINED IN SITU IN THE UPPER PROXIMAL SECTION OF THE ILIAC BRANCH COMPONENT DANGLING TOWARDS THE NATIVE AORTA. A BRIDGING LIMB WAS PLACED SQUEEZING THE INTERNAL ILIAC COMPONENT BETWEEN THE BRIDGING LIMB AND ILIAC BRANCH COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018847 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other