BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS

    MDR report key: 11806146 · Received May 11, 2021

    Report

    Report Number
    2017233-2021-01969
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    February 14, 2020
    Report Date
    June 2, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION CONCLUSIONS: ADDED CODES 4315, 22. H6: COMPONENT CODE: ADDED CODE 515. A SERIAL NUMBER FOR THE GORE® MEDICAL DEVICE INVOLVED IN THIS EVENT COULD NOT BE OBTAINED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS WAS NOT PERFORMED. AS THE ARTICLE PROVIDES DATE RANGE (B)(6) 2010 TO (B)(6) 2018, BEST ESTIMATE OF IMPLANT DATE RANGE IS (B)(6), 2010 TO (B)(6), 2018. CODE 22: ACCORDING TO THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK, REOPERATION. GORE HAS ATTEMPTED TO CONTACT THE CORRESPONDING AUTHOR MULTIPLE TIMES OVER AN EXTENDED PERIOD OF TIME TO OBTAIN ADDITIONAL INFORMATION. AS NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO THIS DAY, THIS EVENT WILL BE PROCESSED AND CLOSED WITH THE INFORMATION PROVIDED. FROM THIS LITERATURE ARTICLE, THE FOLLOWING CASES WERE GENERATED: MPDCASE-(B)(4), REPORT# 2017233-2021-01984. MPDCASE-(B)(4), REPORT# 2017233-2021-01969. MPDCASE-(B)(4), REPORT# 2017233-2021-01970. MPDCASE-(B)(4), REPORT# 2017233-2021-01971. MPDCASE-(B)(4), REPORT# 2017233-2021-01972. MPDCASE-(B)(4), REPORT# 2017233-2021-01975. MPDCASE-(B)(4), REPORT# 2017233-2021-01979. MPDCASE-(B)(4), REPORT# 2017233-2021-01981. MPDCASE-(B)(4), REPORT# 2017233-2021-0198.2 B3: CORRECTED DATE OF EVENT. THE DATE OF EVENT COINCIDES WITH THE PUBLISHED DATE OF THE ARTICLE. B5: UPDATED EVENT DESCRIPTION. D1: CORRECTED BRAND NAME. D6A: CORRECTED IMPLANT DATE H6: TYPE OF INVESTIGATION: REPLACED CODE 4118 WITH CODE 4119. H6: INVESTIGATION FINDINGS: REPLACED CODE 3233 WITH CODE 3221.

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: TONY R. SOARES ET AL, ¿CLINICAL OUTCOMES OF AORTIC ARCH HYBRID REPAIR IN A REAL-WORLD SINGLE-CENTER EXPERIENCE¿, JOURNAL OF VASCULAR SURGERY, 2020 SEP;72(3):813-821.DOI: 10.1016/J.JVS.2019.11.033. EPUB 2020 FEB 14.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED: TONY R. SOARES ET AL, ¿CLINICAL OUTCOMES OF AORTIC ARCH HYBRID REPAIR IN A REAL-WORLD SINGLE-CENTER EXPERIENCE¿, JOURNAL OF VASCULAR SURGERY, 2020 SEP;72(3):813-821.DOI: 10.1016/J.JVS.2019.11.033. EPUB 2020 FEB 14. THIS ARTICLE REPORTS ON EXPERIENCES UTILIZING ENDOVASCULAR STENTS FOR THORACIC AORTIC ARCH ANEURYSM TREATMENT WITH A DEBRANCHING PROCEDURE OF THE SUPRA-AORTIC ARTERIES IN A HYBRID SURGERY SETTING. STUDY END POINTS WERE 30-DAY MORTALITY, 2-YEAR SURVIVAL RATES, POSTOPERATIVE COMPLICATIONS, AND ENDOLEAK AND REINTERVENTION RATES. BETWEEN (B)(6) 2010 AND (B)(6) 2018, 35 MALE PATIENTS WITH A MEDIAN OF 71 YEARS WERE SUBMITTED TO HYBRID SURGERY. REPORTEDLY, 3 GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESES WERE IMPLANTED. THE ARTICLE REPORTS THAT PATIENT #14 EXPERIENCED A TYPE 1 ENDOLEAK AND UNDERWENT AN ADDITIONAL THORACIC AORTIC ENDOVASCULAR PROCEDURE AT 20 MONTHS WITH STENTING OF THE BRACHIOCEPHALIC TRUNK. AS IT IS NOT KNOWN IF IN FACT THIS PATIENT WAS IMPLANTED WITH A GORE® TAG®CONFORMABLE THORACIC ENDOPROSTHESIS, GORE IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: IMPLANT DATE (B)(6) 2018 HAS BEEN PROVIDED AS DATE OF BEST ESTIMATE AND WILL BE REVISED WHEN GORE RECEIVES ADDITIONAL INFORMATION ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: TONY R. SOARES ET AL, ¿CLINICAL OUTCOMES OF AORTIC ARCH HYBRID REPAIR IN A REAL-WORLD SINGLE-CENTER EXPERIENCE¿, JOURNAL OF VASCULAR SURGERY, 2020 SEP;72(3):813-821.DOI: 10.1016/J.JVS.2019.11.033. EPUB 2020 FEB 14. THIS ARTICLE REPORTS ON EXPERIENCES UTILIZING ENDOVASCULAR STENTS FOR THORACIC AORTIC ARCH ANEURYSM TREATMENT WITH A DEBRANCHING PROCEDURE OF THE SUPRA-AORTIC ARTERIES IN A HYBRID SURGERY SETTING. STUDY END POINTS WERE 30-DAY MORTALITY, 2-YEAR SURVIVAL RATES, POSTOPERATIVE COMPLICATIONS, AND ENDOLEAK AND REINTERVENTION RATES. BETWEEN JANUARY 2010 AND DECEMBER 2018, 35 MALE PATIENTS WITH A MEDIAN OF 71 YEARS WERE SUBMITTED TO HYBRID SURGERY. REPORTEDLY, 3 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED. THE ARTICLE REPORTS THAT 7 PATIENTS UNDERWENT AORTA-RELATED REINTERVENTIONS AND THREE OF THEM WERE SUBMITTED TO OPEN SURGERY. EARLY ENDOLEAKS WERE OBSERVED IN SIX PATIENTS (17.1%), EQUALLY DISTRIBUTED BETWEEN TYPE I (N ¼ 3 [8.6%]) AND TYPE II (N ¼ 3 [8.6%]). LATE ENDOLEAKS WERE IDENTIFIED IN 4 OF 24 PATIENTS (16.7%; TYPE I, N ¼ 2 [8.3%]; TYPE II, N ¼ 1 [4.2%]; AND TYPE III, N ¼ 1 [4.2%]). THE ARTICLE REPORTS THAT PATIENT #14 EXPERIENCED A TYPE 1 ENDOLEAK AND UNDERWENT AN ADDITIONAL THORACIC AORTIC ENDOVASCULAR PROCEDURE AT 20 MONTHS WITH STENTING OF THE BRACHIOCEPHALIC TRUNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704801 GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention