BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 12308912 · Received August 11, 2021

    Report

    Report Number
    3007284313-2021-01541
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    June 21, 2021
    Report Date
    October 25, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630103
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ARE BEING REPORTED SEPARATELY UNDER MANUFACTURER REPORT NUMBER (B)(4). (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT WAS UNDERGOING TREATMENT OF AN ASCENDING AORTIC ANEURYSM AS A SUBJECT IN THE(B)(4) CLINICAL STUDY. THE PROCEDURE INCLUDED THE USE OF FOUR GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. DURING THE PROCEDURE A SERIES OF ADVERSE EVENTS OCCURRED WHICH LED TO EVENTUAL INTRAPROCEDURAL DEATH. THE PHYSICIAN STATED THE FOLLOWING: ¿IN SUMMARY, I BELIEVE SHE SUFFERED A SERIES OF STRESSES THAT CUMULATIVELY RESULTED IN HER ARREST WHEN SHE BECAME HYPOXEMIC DURING THE REINTUBATION EVENT. THE SERIES OF STRESSED INCLUDED THE INTERMITTENT HYPOTENSION FROM THE WIRE, TREATED WITH PRESSORS FOR SEVERAL HOURS. HER LEFT PELVIS/LEG WERE ISCHEMIC FOR ABOUT 3.5 HOURS. THE DIFFICULTY ESTABLISHING DISTAL SEAL IN THE DTA, THE LEFT FEMORAL CUT-DOWN ALL CAUSED PROLONGATION OF THE OPERATION. SHE HAD AN ACUTE BLEED FROM THE ACCESS SITE COMPLICATION, WHICH ALTHOUGH IMMEDIATELY RECOGNIZED AND TREATED WAS YET ANOTHER HIT. AFTER ALL THESE EVENTS, I SUSPECT THAT HER HYPOXEMIA EXHAUSTED HER PHYSIOLOGIC RESERVE AND SHE CODED. THE DEVICE PERFORMED AS ANTICIPATED AND THERE WERE NO EVIDENT TECHNICAL COMPLICATIONS WITH THE DEVICE THAT I AM AWARE OF. I BELIEVE THIS WAS A PROCEDURE RELATED EVENT AND NOT A DEVICE RELATED EVENT. WE ARE AWAITING THE AUTOPSY RESULTS TO DETERMINE IF THERE IS ANY ALTERNATIVE EXPLANATION FOR HER CODE AND TO ASSESS HER BRAIN FOR STROKE. GIVEN THE ACUITY FROM ANY EVENT AND HER DEATH, I AM UNSURE IF THE AUTOPSY WILL BE REVEALING FOR STROKE. ¿ THE PHYSICIAN ALSO STATED THE ACCESS INJURY WAS NOT RELATED TO THE GORE SHEATH. ON (B)(6) 2021 THE CLINICAL STUDY DATABASE REVEALED THE FOLLOWING ADDITIONAL INFORMATION: ADVERSE EVENT #2: LEFT ILIAC INJURY: ¿LEFT EXTERNAL ILIAC ARTERY INJURY DURING PLACEMENT OF 26F SHEATH. THIS WAS PROMPTLY DIAGNOSED ON SHEATH REMOVAL AND TREATED WITH BALLOON-EXPANDABLE COVERED STENT (VBX). THE PATIENT HAD RETROPERITONEAL HEMORRHAGE. THIS BLEEDING, IN CONJUNCTION WITH SEVERAL OF EPISODES OF HYPOTENSION LIKELY CONTRIBUTED TO HER DEATH.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203569 GORE DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF2633 00733132630103

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death