BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 20680285 · Received November 14, 2024

    Report

    Report Number
    3007284313-2024-03591
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 14, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630950
    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

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® DRYSEAL FLEX INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU), CAREFUL EVALUATION OF VESSEL SIZE, ANATOMY, TORTUOSITY, AND DISEASE STATE (INCLUDING CALCIFICATION, PLAQUE, AND THROMBUS) IN ACCORDANCE WITH THE OBSERVATION IN THE CT IMAGE OR ANGIOGRAPHY OBTAINED BY PRE-OPERATION/OPERATION OR VISUAL OBSERVATION OBTAINED BY OPERATION IS REQUIRED TO ENSURE SUCCESSFUL USE OF GORE® DRYSEAL FLEX INTRODUCER SHEATH. [IF VESSEL SIZE IS SMALLER THAN THE INTRODUCER SHEATH OUTER DIAMETER OR IF VESSEL IS NOT ADEQUATE FOR ACCESS, MAJOR BLEEDING, VESSEL DAMAGE, OR EMBOLISM, MAY RESULT ADDITIONALLY, THE IFU STATES: 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) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTA ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. IT WAS REPORTED THAT RUPTURE IN THE RIGHT EXTERNAL ILIAC ARTERY WAS CONFIRMED ON THE ACCESS CONFIRMATION ANGIOGRAPHY. TWO ADDITIONAL STENT GRAFTS WERE PLACED TO TREAT THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE DIAMETER OF THE ACCESS VESSEL WAS APPROXIMATELY 7.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224211 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630950

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Required Intervention