BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 15407471 · Received September 12, 2022

    Report

    Report Number
    2017233-2022-03309
    Event Type
    Death
    Date Received
    September 12, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 13, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646999
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED INCLUDE: TGM454515/22346742, UDI: (B)(4). 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) 2022, THIS PATIENT PRESENTED EMERGENTLY FOR TREATMENT OF A CONTAINED RUPTURE OF A ZONE 0 ASCENDING AORTIC THORACIC ANEURYSM. THE PHYSICIAN DECIDED THAT BEST COURSE OF ACTION WAS TO OPEN THE CHEST AND TIE A BIFURCATED GRAFT FROM THE ASCENDING AORTA INTO THE INNOMINATE AND LEFT CAROTID AND THEN PLACE AN ENDOGRAFT TO SEAL THE RUPTURE. AFTER THE PHYSICIAN HAD SEWED IN A BIFURCATED GRAFT TO THE HEAD VESSELS, HE WAS UNABLE TO CONTROL THE BLEEDING AND DECIDED TO IMPLANT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) IN AN ANTEGRADE FASHION UNDER DIRECT VISUALIZATION. THE AORTA WAS PUNCTURED WITH AN 18 GAUGE NEEDLE AND A 260CMX.035 GLIDE WIRE WAS ADVANCED, AND A 90CM BERNSTEIN CATHETER WAS INTRODUCED AND A WIRE EXCHANGE WAS PREFORMED EXCHANGING THE GLIDE WIRE FOR A LUNDERQUIST® 260CMX.035 STIFF WIRE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS ADVANCED 1CM INTO THE AORTA AND THEN CTAG AC WAS ADVANCED THROUGH THE DSF AND DEPLOYED. THERE WAS STILL BLEEDING SO A SECOND CTAG AC WAS DEPLOYED AND THEN BALLOONED. THE PHYSICIAN WAS STILL UNABLE TO CONTROL THE BLEEDING AND THE DECISION WAS MADE TO END THEIR ATTEMPTS TO SAVE THE PATIENT. TIME OF DEATH WAS CALLED. THE PHYSICIAN DID NOT STATE A CAUSE OF DEATH AND REPORTS ALL DEVICES PERFORMED AS INTENDED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810912 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGM454515 00733132646999

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death