BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 21856688 · Received April 17, 2025

    Report

    Report Number
    3007284313-2025-03909
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 9, 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: INVESTIGATION FINDINGS AND CONCLUSIONS WERE UPDATED TO C19 AND D1002, RESPECTIVELY. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    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 AN ENDOVASCULAR TREATMENT (1-DEBRANCHING ZONE 2 TEVAR) FOR CHRONIC TYPE B AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC), ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSION (ZENITH ALPHA), AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). TWO ZENITH ALPHAS WERE FIRSTLY PLACED IN THE DISTAL DESCENDING AORTA AND THEN, TGMR404020J OF CTAG AC WAS PLACED JUST DISTAL TO THE LEFT COMMON CAROTID ARTERY. DURING THE DEPLOYMENT OF CTAG AC, THE DEVICE SLIGHTLY MOVED DISTALLY AND FURTHER ON BALLOONING. THEREFORE, ANOTHER CTAG AC PLACEMENT WAS NEEDED. DURING ADVANCING THE SECOND CTAG AC (TGMR404015J) TO THE TARGETED SITE, THE DSF SHEATH WAS ACCIDENTALLY PULLED OUT OF THE PATIENT. THE DSF SHEATH COULD NOT BE REINSERTED AS IT GOT STUCK ON THE PERCLOSE DEVICE. THUS, THE SECOND CTAG AC THAT HAD BEEN ALREADY BEEN INSERTED BECAME UNABLE TO BE REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE CTAG AC WITHOUT SHEATH, BUT IT GOT STUCK ON THE PERCLOSE DEVICE AND THE ATTEMPT WAS NOT SUCCEEDED. THEREFORE, ANOTHER CUT-DOWN WAS MADE ON THE RIGHT COMMON FEMORAL ARTERY AND THE CTAG AC WAS SURGICALLY REMOVED. ANOTHER DSF SHEATH WAS INSERTED FROM THE NEW CUT-DOWN SITE AND THE SECOND CTAG AC WAS REINSERTED AND PLACED CORRECTLY. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763965 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630073

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention