BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 21315598 · Received February 5, 2025

    Report

    Report Number
    3007284313-2025-03743
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 14, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630073
    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

    H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE D12: 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.) AND BLEEDING.

    Additional Manufacturer Narrative · 0

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. 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) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. A 22FR SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY. THE SHEATH WAS REMOVED AFTER ALL STENT GRAFTS WERE DEPLOYED. AFTER THAT, A DECLINE IN VITAL SIGNS WAS OBSERVED. CONTRAST IMAGING REVEALED A RUPTURE OF THE LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN IMPLANTED TWO ADDITIONAL STENT GRAFTS IN THE LEFT EXTERNAL ILIAC ARTERY AS A TREATMENT. ALSO, THE PUNCTURE SITE OF THE LEFT FEMORAL ARTERY WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE ACCESS VESSEL WAS ORIGINALLY NARROW, BUT I DID NOT EXPECT ANY DAMAGE MORE THAN DISSECTION. THE PATIENT HAD A HISTORY OF AORTIC DISSECTION, WHICH MAY HAVE CONTRIBUTED TO VASCULAR FRAGILITY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50588 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630073

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention