BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15592766 · Received October 12, 2022

    Report

    Report Number
    2017233-2022-03399
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 11, 2022
    Report Date
    November 20, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646821
    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 DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: CATALOG #: TGMR313120, SERIAL #: (B)(4), UDI #: (B)(4) AS THE SAME SYSTEM OF COMPONENTS. CATALOG #: TAC124020A, SERIAL #: (B)(4) , UDI #: (B)(4) WHICH IS CAPTURED IN MANUFACTURER REPORT #: 2017233-2022-03398. CATALOG #: TSB121506A, SERIAL #: (B)(4), UDI #: (B)(4) WHICH IS CAPTURED IN MANUFACTURER REPORT #: 2017233-2022-03398. CATALOG #: BCL2645, SERIAL #: (B)(4), UDI #: (B)(4). CATALOG #: DSF2665, SERIAL #: (B)(4), UDI #: (B)(4). AGE AT THE TIME OF EVENT/DATE OF BIRTH: ASKED BUT UNAVAILABLE. PATIENT WEIGHT: ASKED BUT UNAVAILABLE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE. 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 FINDINGS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION CONCLUSIONS: CODE D12 ADDED. ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS OR COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY 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). H.6. INVESTIGATION FINDINGS: CODE C21 UPDATED TO CODE C19. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15.

    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
    2600830 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGMR373720 00733132646821

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other