BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17831215 · Received September 28, 2023

    Report

    Report Number
    3007284313-2023-02776
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 31, 2023
    Report Date
    November 8, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. TYPE OF INVESTIGATION: ADDED B14: ANALYSIS OF PRODUCTION RECORDS. H.6. INVESTIGATION FINDINGS CODE C21 UPDATED TO C16. H.6.: MEDICAL DEVICE PROBLEM CODE A26 UPDATED TO A02. H.6.: INVESTIGATION CONCLUSIONS: D16 UPDATED TO D0301. H.3.: DEVICE EVALUATION: THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE LEADING END OF THE DELIVERY CATHETER IS SEPARATED FROM THE REST OF THE CATHETER. THE SEPARATION HAS OCCURRED AT THE MID-OLIVE. THERE WAS NO OLIVE BOND RESIDUE OBSERVED AT THE POLYIMIDE/OLIVE BOND LOCATION. THE LEADING OLIVE IS STILL ATTACHED TO THE SEPARATED PORTION OF THE POLYIMIDE. BASED ON THE FINDINGS OF THIS EVALUATION, THE PHYSICIAN¿S OBSERVATION THAT ¿THE PROXIMAL PART/LEADING END OF THE RLT281412J CATHETER HAD BEEN SEPARATED AT AROUND THE MID-OLIVE¿ COULD BE CONFIRMED. THE LIKELY CAUSE FOR THE REPORTED OBSERVATION OF ¿THE PROXIMAL PART/LEADING END OF THE RLT281412J CATHETER HAD BEEN SEPARATED AT AROUND THE MID-OLIVE¿ IS AN INSUFFICIENT GUIDEWIRE LUMEN BOND.

    Additional Manufacturer Narrative · 0

    H.6.: CODE E2403: USED AS NO ADVERSE EVENT TO THE PATIENT WAS REPORTED, AND THE PATIENT TOLERATED THE PROCEDURE. H.6.: CODE B22: RESULTS PENDING COMPLETION OF INVESTIGATION. H.6.: CODE C21: RESULTS PENDING COMPLETION OF INVESTIGATION. H.6.: D16: CONCLUSION NOT YET AVAILABLE. H.6.: CODE A26: RESULTS PENDING COMPLETION OF INVESTIGATION. 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 INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THE PROCEDURE, A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT281412J) WAS DEPLOYED SUCCESSFULLY USING A SHEATH (DSF1833), AND THE DELIVERY CATHETER OF RLT281412J WAS REMOVED THROUGH THE DSF1833. SUBSEQUENTLY, WHEN A CONTRALATERAL LEG ENDOPROSTHESIS (PLC201400J) WAS INSERTED THROUGH THE DSF1833, TWO LEADING OLIVES WERE OBSERVED ON FLUOROSCOPY, SO THE 201400J WAS DECIDED TO BE RETRIEVED. CHECKING WITH THE RETRIEVED PLC201400J, IT WAS OBSERVED THAT THE PROXIMAL PART/LEADING END OF THE RLT281412J CATHETER WAS REMOVED TOGETHER WITH THE PLC201400J (TRAILING PART OF THE PLT281412J LEADING END WAS STICKED TO THE LEADING OLIVE OF THE PLC201400J). IT WAS CONSIDERED THAT THE PROXIMAL PART/LEADING END OF THE RLT281412J CATHETER HAD BEEN SEPARATED AT AROUND THE MID-OLIVE, IN THE SHEATH, WHEN THE CATHETER WAS REMOVED. THE PROCEDURE WAS CONTINUED USING THE SAME PLC201400J AFTER FLUSHING THE CATHETER. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED, AND THE PATIENT TOLERATED THE PROCEDURE. THE REMOVED CATHETER AND THE SHEATH WILL BE RETURNED TO GORE FOR INVESTIGATION. THE PHYSICIAN REPORTEDLY STATED: NO UNUSUAL MANIPULATION WERE PERFORMED. I DID NOT FEEL ANY PARTICULAR RESISTANCE WHEN REMOVING THE RLT281412J DELIVERY CATHETER. I GUESS THE DELIVERY CATHETER MAY HAVE BEEN IN A CONDITION TO BE EASILY SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836351 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male