BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 9594624 · Received January 16, 2020

    Report

    Report Number
    2017233-2020-00037
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    May 3, 2018
    Report Date
    June 8, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5 EVENT DESCRIPTION: UPDATED PART OF EVENT DESCRIPTION. H6. RESULTS CODE 2: ADDED CODE. H6. METHOD CODE 3: ADDED CODE.

    Additional Manufacturer Narrative · 0

    H6: CODE 22 - ACCORDING TO THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: DISSECTION AND SURGICAL CONVERSION. THE EXPLANTED CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS TGE404015 / 8953066 WAS RETURNED TO GEPROVAS AND AN ENGINEERING EVALUATION WAS PERFORMED. THE FOLLOWING IS A SUMMARY OF THE EI OBSERVATIONS: TISSUE PRESENT: YES. LIGHT TAN/YELLOW TISSUE LIGHTLY COVERED THE LUMINAL AND ABLUMINAL SURFACES. A TAG OF YELLOW/TAN TISSUE EXTENDED DISTALLY, FROM THE DISTAL ASPECT. A SMALL FOCI OF TAN/BROWN TO DARK BROWN TISSUE WAS ALSO PRESENT ON THE LUMINAL SURFACE. THE LUMEN WAS WIDELY PATENT. THE PROXIMAL ASPECT OF THE DEVICE FRAGMENT WAS FULLY TRANSECTED. THE VISIBLE EDGES OF THE DISTAL END OF THE DEVICE FRAGMENT WERE NOT CUT; TISSUE COVERED PORTIONS OF THE EDGE. THE INTEGRITY OF THE ENTIRE DISTAL END COULD NOT BE ANALYZED WITH THE INFORMATION PROVIDED. A LONGITUDINAL TRANSECTION WAS PRESENT IN ONE REGION OF THE DEVICE FRAGMENT. FROM GROSS IMAGES ALL MATERIAL DISRUPTIONS (I.E., MATERIAL TRANSECTIONS/CUTS), APPEAR TO BE CONSISTENT WITH CUTTING BY SHARP SURGICAL INSTRUMENTS (I.E., SCALPEL OR SCISSORS), LIKELY USED DURING THE EXPLANT PROCEDURE. REQUEST FOR ADDITIONAL ANALYSIS: NO. REASON: MATERIAL DISRUPTIONS ARE CONSISTENT WITH THOSE CAUSED BY SURGICAL INSTRUMENTATION DURING THE EXPLANT PROCESS. BASED ON THE EI¿S REVIEW OF THE GEPROVAS REPORT, NO ADDITIONAL ANALYSIS IS REQUESTED.

    Description of Event or Problem · 0

    ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE TYPE B COMPLICATED THORACIC AORTIC DISSECTION.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE TYPE B COMPLICATED THORACIC AORTIC DISSECTION. ON (B)(6) 2018, AFTER ABOUT 6 YEARS, THE ENDOGRAFT WAS EXPLANTED AS DISEASE PROGRESSION HAD LED TO ANEURYSM ENLARGEMENT WITH THE PATIENT RECEIVING A PROSTHETIC REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61422 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8953066

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R