BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 8472563 · Received April 2, 2019

    Report

    Report Number
    2017233-2019-00194
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    March 7, 2019
    Report Date
    May 28, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: ¿ENDOVASCULAR REPAIR OF BLUNT THORACIC AORTIC TRAUMA: IS POSTIMPLANT HYPERTENSION AN INCIDENTAL FINDING?¿ (KONSTANTINOS TIGKIROPOULOS, ET.AL, VANN VASC SURG, 2018, 50: 160-166, PUBLISHED ONLINE ON (B)(6) 2018). THE ARTICLE ANALYZED THE OUTCOME OF 23 PATIENTS THAT PRESENTED WITH BLUNT THORACIC AORTIC TRAUMA (BTAI) THAT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) BETWEEN JANUARY 2005 AND JANUARY 2016. PATIENT 9 THAT WAS TREATED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES SHOWED SIGNS OF PROXIMAL COLLAPSE OF THE ENDOGRAFT ON THE SECOND POSTOPERATIVE DAY. HE WAS URGENTLY TRANSFERRED TO THE OPERATING THEATER, AND A PROXIMAL ENDOGRAFT EXTENSION WAS PERFORMED ALONG WITH APPROPRIATE BALLOON DILATATION AND AN INNOMINATE TO THE LEFT CAROTID BYPASS. THE PHYSICIAN STATED THAT THE AORTIC ARCH OF THE PATIENT HAD AN ACUTE ANGLE THAT MIGHT HAVE CONTRIBUTED TO THE COLLAPSE OF THE DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: ¿ENDOVASCULAR REPAIR OF BLUNT THORACIC AORTIC TRAUMA: IS POSTIMPLANT HYPERTENSION AN INCIDENTAL FINDING?¿ (KONSTANTINOS TIGKIROPOULOS, ET.AL, VANN VASC SURG, 2018, 50: 160-166, PUBLISHED ONLINE ON MARCH 7, 2018). THE ARTICLE ANALYZED THE OUTCOME OF 23 PATIENTS THAT PRESENTED WITH BLUNT THORACIC AORTIC TRAUMA (BTAI) THAT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) BETWEEN JANUARY 2005 AND JANUARY 2016. PATIENT 9 THAT WAS TREATED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES SHOWED SIGNS OF PROXIMAL COLLAPSE OF THE ENDOGRAFT ON THE SECOND POSTOPERATIVE DAY. HE WAS URGENTLY TRANSFERRED TO THE OPERATING THEATER, AND A PROXIMAL ENDOGRAFT EXTENSION WAS PERFORMED ALONG WITH APPROPRIATE BALLOON DILATATION AND AN INNOMINATE TO THE LEFT CAROTID BYPASS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268535 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention