BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 19824730 · Received July 25, 2024

    Report

    Report Number
    3007284313-2024-03385
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 10, 2024
    Report Date
    July 25, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630028
    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), 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 INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT TOTAL ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK TREATMENT OF A THORACIC ARCH ANEURYSM. ON JULY 10, 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE THORACIC ARCH ANEURYSM USING ZENITH ALPHA DEVICE. ON THE SAME DAY, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING ENDURANT AORTA EXTENSION, GORE® EXCLUDER® AAA ENDOPROSTHESES, AND THREE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). TWO 16 FR DSF DEVICES WERE USED FOR BILATERAL ACCESSES, DSF1633/(B)(6) WAS IN THE RIGHT ACCESS AND DSF1633/(B)(6) WAS IN THE LEFT ACCESS. ONE 14 FR DSF WAS SWITCHED FOR A CONTRALATERAL LEG COMPONENT IN THE LEFT ACCESS. AFTER ALL STENT GRAFTS WERE IMPLANTED, A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED. ADDITIONALLY BARE METAL STENT (E-LUMINEXX 12 MM - 6 CM) WAS IMPLANTED. INTIMAL DAMAGES WERE OBSERVED AT BILATERAL INSERTION SITES AND SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364266 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630028

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention