BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 20680817 · Received November 14, 2024

    Report

    Report Number
    3007284313-2024-03594
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 14, 2024
    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

    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. 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.). 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 WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A PROXIMAL TYPE IA ENDOLEAK AND DSINE OF A NON-GORE STENT GRAFT USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A COIL EMBOLIZATION WAS PERFORMED TO PROXIMAL LANDING ZONE OF THE NON-GORE DEVICE AND THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. THE SHEATH WAS ADVANCED SMOOTHLY. THE FIRST GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313120J) WAS IMPLANTED DISTALLY AND THE SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR404015J) WAS IMPLANTED PROXIMALLY. AFTER ALL DEVICES WERE IMPLANTED, DSINE WAS RESOLVED BUT THE TYPE IA ENDOLEAK REMAINS. THE PHYSICIAN DECIDED TO MONITOR THE TYPE IA ENDOLEAK. AN ANGIOGRAPHY FOR THE ACCESS VESSEL REVEALED A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY TO THE RIGHT FEMORAL ARTERY. A STENT WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY TO THE RIGHT COMMON FEMORAL ARTERY. IT WAS CONFIRMED THAT THE BLOOD FLOW WAS WELL. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT IT WAS NOT NOTICED THAT THE DISSECTION OCCURRED BECAUSE THERE WAS NO RESISTANCE DURING THE SHEATH INSERTION. REPORTEDLY, THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY TO THE FEMORAL ARTERY WAS 7.6 MM ¿ 8.7MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232117 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630073

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention