BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 17026907 · Received May 30, 2023

    Report

    Report Number
    3007284313-2023-02527
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 13, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132629961
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4: PMA/510K NUMBER CORRECTED TO K160254

    Additional Manufacturer Narrative · 0

    H6: B18, THE DEVICE WAS DISCARDED AT THE TREATING FACILITY AND WAS THEREFORE NOT AVAILABLE FOR ANALYSIS. H6: C19, THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED THE PRODUCT MET SPECIFICATIONS AND PROCEDURES. IT SHOULD BE NOTED THE GORE® DRYSEAL FLEX INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATE ¿ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, VASCULAR TRAUMA (I.E., DISSECTION, RUPTURE, PERFORATION, TEAR, ETC.).¿ 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

    ON (B)(6)2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE LEFT COMMON ILIAC ARTERY ANEURYSM WAS NOTED BUT IT WAS DECIDED TO BE MONITORED. A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY WAS CONFIRMED BUT THE PROCEDURE WAS COMPLETED (CAPTURED IN (B)(4).) ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED DUE TO AN ENLARGEMENT OF THE LEFT COMMON ILIAC ARTERY ANEURYSM (UNTREATMENT SITE) USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® MOLDING & OCCLUSION BALLOON CATHETER. THE SHEATH WAS INSERTED THROUGH THE LEFT COMMON FEMORAL ARTERY. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND AN ADDITIONAL STENT GRAFT WAS EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY. AFTER THE STENT GRAFT WAS IMPLANTED, BALLOONING WAS PERFORMED. ACCESS ANGIOGRAPHY AFTER STENT GRAFT PLACEMENT CONFIRMED A LOCALIZED DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY. THE LOCALIZED DISSECTION WAS CONFIRMED DISTAL FROM THE STENT GRAFT PLACEMENT, AND IT WAS REPORTED THAT THE DISSECTION MAY HAVE FORMED DURING SHEATH INSERTION OR BALLOONING. NO ADDITIONAL TREATMENT WAS PERFORMED FOR THE DISSECTION AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970645 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF1233 00733132629961

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Hospitalization