BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 12132541 · Received July 7, 2021

    Report

    Report Number
    2017233-2021-02143
    Event Type
    Death
    Date Received
    July 7, 2021
    Date of Event
    June 21, 2021
    Report Date
    February 4, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646852
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FROM STUDY CENTER INDICATED THAT THE DEVICES WERE NOT RESPONSIBLE FOR PATIENT DEATH. THE PREVIOUS REPORT IS HEREBY RETRACTED.

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. D.10. THE FOLLOWING ADDITIONAL DEVICES WERE INVESTIGATED: TGMR404020 UDI: (B)(4) SN# (B)(6). TGM454515 UDI: (B)(4) SN# (B)(6). TGMR404020 UDI: (B)(4) SN# (B)(6).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL DEVICES WERE INVESTIGATED AS IT IS NOT KNOWN WHICH DEVICE, IF ANY, CAUSED OR CONTRIBUTED TO THE PATIENT DEATH: ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: RESPIRATORY FAILURE, EMBOLIZATION AND DEATH.

    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 SSB 1102 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023925 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGMR404020 00733132646852

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death SEE H.10./11.