BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 20115765 · Received September 1, 2024

    Report

    Report Number
    3007284313-2024-03461
    Event Type
    Death
    Date Received
    September 1, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 2, 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 INSTRUCTION FOR USE (IFU), THE POTENTIAL ADVERSE EVENTS WITH THE USE OF DEVICE MAY INCLUDE BUT ARE NOT LIMITED TO: TRANSIENT OR PERMANENT ISCHEMIA, DEATH. 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

    ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING TWO VALIANT THORACIC STENT GRAFTS (MEDTRONIC JAPAN CO., LTD). A GORE® DRYSEAL FLEX INTRODUCER SHEATH (SHEATH) WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT PATIENT¿S RIGHT ACCESS VESSEL (FROM THE RIGHT COMMON ILIAC ARTERY (CIA) JUST BELOW THE TERMINAL AORTA THROUGH EXTERNAL ILIAC ARTERY (EIA) TO COMMON FEMORAL ARTERY (CFA)) WHERE THE SHEATH HAD BEEN INSERTED DURING THE PROCEDURE, BECAME OCCLUDED CAUSING PERFUSION INJURY TO THE PATIENT. AS A TREATMENT, A THROMBECTOMY AND A FEMORAL-FEMORAL CROSSOVER BYPASS SURGERY WAS PERFORMED ON (B)(6) 2024, HOWEVER, THE PATIENT WENT INTO CARDIOPULMONARY ARREST DUE TO THE REPERFUSION INJURY. AFTER FAILING TO CONTROL THE BLOOD PRESSURE, THE PATIENT EXPIRED ON (B)(6) 2024. ACCORDING TO THE OPERATING PHYSICIAN, THE PATIENT¿S ACCESS VESSELS ON THE RIGHT SIDE HAD UNFAVORABLE ANATOMY. THE RIGHT CIA AND THE RIGHT EIA MEASURED 8.2MM. THE RIGHT CIA AND THE RIGHT CFA WERE HIGHLY CALCIFIED. MILD STENOSIS WERE NOTED AT TERMINAL AORTA. THE PHYSICIAN SUSPECTED THE PATIENT WAS EXPOSED TO ISCHEMIC CONDITIONS FOR TOO LONG DUE TO THE USE OF THE LARGE-SIZED SHEATH DURING THE PROCEDURE, CAUSING THE PERFUSION INJURY THAT LEAD TO THE PATIENT'S DEATH. THE PHYSICIAN MADE NO ALLEGATION AGAINST THE PERFORMANCE OF THE SHEATH, AND HE DOES NOT THINK THE EVENT IS ATTRIBUTED TO THE SHEATH MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079066 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630073

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death