BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15060649 · Received July 19, 2022

    Report

    Report Number
    3007284313-2022-02038
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    June 21, 2022
    Report Date
    August 30, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622535
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION WAS REQUESTED BUT WAS NOT MADE AVAILABLE: PATIENT WEIGHT, MEDICATIONS AND COMORBIDITIES (B)(4). 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

    H1 / H2: TYPE OF REPORTABLE EVENT (CHECK ALL THAT APPLY) IF FOLLOW UP WHAT TYPE. SERIOUS INJURY REPLACED WITH PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 0

    H6. CODE C20, NO FINDINGS AVAILABLE AND H6. CODE D15, CAUSE NOT ESTABLISHED. AN ENGINEERING EVALUATION OF THE EVENT WAS PERFORMED. THE DEVICE EVALUATION WAS PERFORMED BASED ON AN EVENT DESCRIPTION AS REPORTED TO GORE AND A PHOTO ATTACHED TO THE SMARTSOLVE CASE AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EVALUATION OF THE PHOTO SHOWED THAT THE LOCK PIN APPEARS TO BE DISLODGED FROM ITS SEATING IN THE LEADING OLIVE. BASED ON THE FINDINGS FROM THIS EVALUATION, THE PHYSICIAN¿S OBSERVATION THAT ¿THE ANCHORING PIN THAT HOLDS THE RESHAPING MECHANISM BECAME DISLODGED FROM THE WHITE NOSECONE¿ WAS CONFIRMED. THE PHYSICIAN¿S OBSERVATION THAT THE WIRE ¿PIERCED THE VALVE OF THE SHEATH¿ COULD NOT BE CONFIRMED FROM THE PROVIDED IMAGE. THE LIKELY CAUSE FOR THE DISLODGED LOCK PIN AND PIERCED VALVE OF THE SHEATH COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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. B7. THE EVENT DESCRIPTION WAS UPDATED TO INCLUDE ADDITIONAL DETAILS OF THE EVENT AS COMMUNICATED. G3/G4. DATE RECEIVED BY MANUFACTURER WAS UPDATED TO 30-AUG-2022 AS EVALUATION ACTIVITIES WERE COMPLETED IN FULL ON THIS DAY. H6. CODE 3233, RESULTS PENDING COMPLETION OF INVESTIGATION WAS REPLACED WITH CODE C20, NO FINDINGS AVAILABLE

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AS REPORTED, DURING THE PROCEDURE A GORE® EXCLUDER® AAA ENDOPROSTHESIS, TRUNK IPSILATERAL LEG COMPONENT (RLT281414) WAS USED WITH A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AS REPORTED, THERE WAS AN ATTEMPT TO PUSH THE GORE® EXCLUDER® AAA ENDOPROSTHESIS THROUGH THE SHEATH BUT ¿THE ANCHORING PIN THAT HOLDS THE RESHAPING MECHANISM BECAME DISLODGED FROM THE WHITE NOSECONE AND PIERCED THE VALVE OF THE SHEATH¿. AS REPORTED, THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE SAME PROTRUSION THAT HAD PUNCTURED THE VALVE WAS EXTENDED OUT FROM THE TIP OF THE CATHETER. AN IMAGE OF THE PROTRUSION WAS PROVIDED FOR CONSIDERATION. AS REPORTED, AN ALTERNATE GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

    Description of Event or Problem · 0

    ON (B)(6), 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AS REPORTED, DURING THE PROCEDURE A GORE® EXCLUDER® AAA ENDOPROSTHESIS, TRUNK IPSILATERAL LEG COMPONENT (RLT281414) WAS USED WITH A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AS REPORTED, THERE WAS AN ATTEMPT TO PUSH THE GORE® EXCLUDER® AAA ENDOPROSTHESIS THROUGH THE SHEATH BUT ¿THE ANCHORING PIN THAT HOLDS THE RESHAPING MECHANISM BECAME DISLODGED FROM THE WHITE NOSECONE AND PIERCED THE VALVE OF THE SHEATH¿. REPORTEDLY, THE SURGICAL TEAM KEPT PUSHING ON THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR A TIME NOT REALIZING WHAT HAD HAPPENED. AS REPORTED, THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE SAME PROTRUSION THAT HAD PUNCTURED THE VALVE WAS EXTENDED OUT FROM THE TIP OF THE CATHETER. AN IMAGE OF THE PROTRUSION WAS PROVIDED FOR CONSIDERATION. AS REPORTED, THERE WERE NO CLINICAL ISSUES RELATED TO THE BLOOD LOSS. AS REPORTED, THE SHEATH WAS IMMEDIATELY TWISTED PREVENTING BLOOD LOSS WHILE THE REPLACEMENT SHEATH WAS PREPPED. AS REPORTED, AN ALTERNATE DSF AND RLT281414 WERE USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717465 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT281414 00733132622535

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other