BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 15592755 · Received October 12, 2022

    Report

    Report Number
    2017233-2022-03398
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 11, 2022
    Report Date
    February 8, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132654246
    PMA / PMN Number
    P210032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: CATALOG #TSB121506A/ SERIAL #(B)(4), UDI #(B)(4) AS THE SAME SYSTEM OF COMPONENTS. CATALOG #TGMR373720/ SERIAL #(B)(4), UDI #(B)(4). CATALOG #TTGMR313120/ SERIAL #(B)(4), UDI #(B)(4). CATALOG #BCL2645/ SERIAL #(B)(4), UDI #(B)(4). CATALOG #DSF2665/ SERIAL #(B)(4), UDI #(B)(4). (B)(4). ACCORDING TO THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS INCLUDE, BUT ARE NOT LIMITED TO, EMBOLISM (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA, PERIPHERAL MALPERFUSION OR ISCHEMIA, AND NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS). 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION CONCLUSIONS CODE D15 AND D12 REMAIN UNCHANGED. UPON REVIEW OF THE EVENT BY THE PRODUCT SPECIALIST IT WAS DETERMINED THAT THE TSB121506A (SERIAL #(B)(6)) GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS - SIDE BRANCH DID NOT CAUSE OR CONTRIBUTE TO THE SPINAL CORD ISCHEMIA EVENT. AS THERE ARE NO ALLEGATIONS OF DEFICIENCY AGAINST THE SIDE BRANCH DEVICE, THIS DEVICE WILL NOT BE INCLUDED IN THE REPORT OR INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENCY TREATMENT OF A SYMPTOMATIC ZONE 0 DISSECTING ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER WERE USED AS ACCESSORIES IN THE PROCEDURE. THE PATIENT'S ANATOMY WAS REPORTED TO BE EXTENSIVELY TORTUOUS. ON (B)(6) 2022, THE GORE REPRESENTATIVE WAS MADE AWARE THAT THE PATIENT HAD SPINAL CORD ISCHEMIA WHICH WAS OBSERVED ON THE EVENING OF THE INDEX PROCEDURE. IT WAS REPORTED THAT A NON-PROPHYLACTIC SPINAL DRAIN WAS PLACED POST-PROCEDURE AND A PLAN WAS MADE TO DISCHARGE THE PATIENT TO A REHAB CENTER. THE SPINAL CORD ISCHEMIA IS ONGOING. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS ARE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567024 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TAC124020A 00733132654246

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other