BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 21684725 · Received March 24, 2025

    Report

    Report Number
    3007284313-2025-03848
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 24, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132658893
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE B18-THE DEVICE WAS DISCARDED AND, THEREFORE, WAS NOT AVAILABLE FOR ENGINEERING ANALYSIS BY GORE. H6: CODE C19- DEVICE HISTORY REVIEW WAS PERFORMED BY CREGANNA MEDICAL, AND STATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: TWO TIME-POINTS AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA DATED (B)(6) 2024 HAS SAVED SCENES IN TERA RECON AND POST-IMPLANTATION CTA DATED (B)(6) 2025. PRE-IMPLANTATION CTA IMAGE SCENE SAVED FROM THE (B)(6) 2024 TIME-POINT SHOWS: RIGHT RENAL ARTERY (RRA) DIAMETERS APPEAR TO RANGE FROM 4.1MM ¿ 7.5MM (PROXIMAL). THIS SCENE WAS SAVED BY THE FSA OR CAS. CANNOT CONFIRM WITHOUT DICOM IMAGING. POST-IMPLANTATION CTA DATED (B)(6) 2025 SHOWS: OBLIQUE 3D IMAGES SHOW A STEEP ANGULATION INTO THE RRA. THE LENGTH OF THE DEVICES IMPLANTED IN THE RRA APPEARS TO BE 9.9CM, BY OUTER CURVE LENGTH. THE AMOUNT OF STENT OVERLAP APPEARS TO BE 1CM, BY OUTER CURVE LENGTH. THE LENGTH OF THE FIRST (PROXIMAL) IMPLANTED STENT IN THE RRA APPEARS TO BE 3.6CM, BY OUTER CURVE LENGTH. (BXB073902A). THE LENGTH OF THE DISTAL STENT IMPLANTED IN THE RRA APPEARS TO BE ~7.4CM, BY OUTER CURVE LENGTH. (BXB067902A). A 3D IMAGE SHOWS A STEEP ANGULATION INTO THE LSA. THE LENGTH FROM THE LSA OSTIUM TO THE FIRST BRANCH APPEARS TO BE ~3.1CM, BY CENTERLINE. LSA DIAMETERS APPEAR TO RANGE FROM 7.3MM - 11.7MM (PROXIMAL). RECONSTRUCTION IMAGES SHOW A DISSECTION AT THE LEVEL OF THE PROXIMAL LSA. THE TEAR IS LOCATED 1.6MM PROXIMAL TO THE DISTAL LSA BORDER. 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 HAVE NOT 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) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE (GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS) WAS IMPLANTED TO TREAT AN ANEURYSM, UTILIZING TWO 12FR SHEATHS. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES. ON (B)(6)2025, POST-PROCEDURE, A CT IMAGE REVEALED THE PATIENT DEVELOPED A TYPE 1B DISSECTION AROUND THE LEFT SUBCLAVIAN ARTERY (LSA). IT IS UNKNOWN WHICH 12FR SHEATH WAS USED IN THE LSA. ON THE SAME DAY, A REINTERVENTION SURGERY WAS PERFORMED, IN WHICH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS GRAFT DEVICE WAS IMPLANTED IN ZONE 2. THE CT IMAGING ALSO SHOWED THROMBOSED VBX STENTS THAT WERE IMPLANTED IN THE RIGHT RENAL ARTERY (RRA). DISTAL DISSECTION WAS ALSO NOTED FOR THE RRA. ON THE SAME DAY, THE DISSECTION AND THE THROMBOSED RRA STENTS WERE TREATED DURING THE INTERVENTION. THROMBECTOMY WAS DONE, AND A BARE METAL STENT WAS USED FOR 2CM DISTAL EXTENSION. THE IMPLANTED VBX STENTS WERE ALSO RELINED FOR RADIAL STRENGTH WITH IMPLANTATION OF A 7X79 VBX DEVICE. THE 6 X 79 VBX DEVICE WAS IMPLANTED MOST DISTAL IN THE RIGHT RRA. AS REPORTED, THE CAUSE OF THROMBOSIS IS UNKNOWN; HOWEVER, PHYSICIAN STATED THE OCCLUSION COULD BE RELATED TO THE RRA DISSECTION. IT WAS ALSO REPORTED THERE WERE NO DIFFICULTIES ADVANCING THE SHEATH, SO THE CAUSE OF THE TYPE1B DISSECTION REMAINS UNKNOWN AS THERE WERE NO ISSUES NOTED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100336 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132658893

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention