BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 6072025 · Received November 2, 2016

    Report

    Report Number
    2017233-2016-00836
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    August 19, 2013
    Report Date
    November 7, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. TGT4015/8233021 (B)(4). TGT4015/8526182 (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING ONE GORE TAG THORACIC ENDOPROSTHESIS (TGT4015/8233021). PRIOR TO THE DEVICE IMPLANT, A BYPASS SURGERY WAS PERFORMED FROM THE LEFT COMMON CAROTID ARTERY TO LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS IMPLANTED WITH NO REPORTED ISSUES, AND THEN THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. NO ISSUES WERE REPORTED. THE DIAMETER OF THE ANEURYSM WAS 54MM. ON (B)(6) 2011, SIX MONTH FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM WAS 49MM. NO ISSUES WERE REPORTED. ON (B)(6) 2013, TWO YEAR FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM ENLARGED TO 70MM. AN ENDOLEAK WAS OBSERVED, REPORTED TO BE A DISTAL TYPE I ENDOLEAK. THE ENDOLEAK WAS REPORTED TO BE DEVICE-RELATED. ON (B)(6) 2013, RE-INTERVENTION WAS PERFORMED TO REPAIR THE ENDOLEAK WHEREAS AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS (TGT4015/8526182) WAS IMPLANTED TO RELINE THE PREVIOUSLY IMPLANTED DEVICE. POST-OPERATIVE CT IMAGES SHOWED THAT THE ENDOLEAK PERSISTED. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT DEVELOPED PULMONARY HEMORRHAGE. THE HEMORRHAGE WAS REPORTED TO BE DEVICE-RELATED. THE CAUSE OF THE PULMONARY HEMORRHAGE WAS AORTOBRONCHIAL FISTULA. THE LOCATION AND CAUSE OF THE FISTULA WERE UNKNOWN. ON (B)(6) 2014, THREE YEAR FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM FURTHER ENLARGED TO 91MM. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ON (B)(6) 2014, RE-INTERVENTION WAS PERFORMED TO REPAIR THE PULMONARY HEMORRHAGE WHEREAS A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS (TGU454515J/12552619) WAS ADDITIONALLY IMPLANTED. ALSO, A BYPASS SURGERY WAS PERFORMED FROM THE RIGHT AXILLARY ARTERY TO THE BYPASS GRAFT. THE LEFT SUBCLAVIAN ARTERY WAS COIL-EMBOLIZED. ACCORDING TO THE CRO IN (B)(6), NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING ONE GORE® TAG® THORACIC ENDOPROSTHESIS (TGT4015/8233021). PRIOR TO THE DEVICE IMPLANT, A BYPASS SURGERY WAS PERFORMED FROM THE LEFT COMMON CAROTID ARTERY TO LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS IMPLANTED WITH NO REPORTED ISSUES, AND THEN THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. NO ISSUES WERE REPORTED. THE DIAMETER OF THE ANEURYSM WAS 54MM. ON (B)(6) 2011, SIX MONTH FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM WAS 49MM. NO ISSUES WERE REPORTED. ON (B)(6) 2013, TWO YEAR FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM ENLARGED TO 70MM. AN ENDOLEAK WAS OBSERVED, REPORTED TO BE A DISTAL TYPE I ENDOLEAK. THE ENDOLEAK WAS REPORTED TO BE DEVICE-RELATED. ON (B)(6) 2013, RE-INTERVENTION WAS PERFORMED TO REPAIR THE ENDOLEAK WHEREAS AN ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESIS (TGT4015/ 8526182) WAS IMPLANTED TO RELINE THE PREVIOUSLY IMPLANTED DEVICE. POST-OPERATIVE CT IMAGES SHOWED THAT THE ENDOLEAK PERSISTED. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT DEVELOPED PULMONARY HEMORRHAGE ((B)(4)). THE HEMORRHAGE WAS REPORTED TO BE DEVICE-RELATED. ON (B)(6) 2014, THREE YEAR FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM FURTHER ENLARGED TO 91MM. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ON (B)(6) 2014, RE-INTERVENTION WAS PERFORMED TO REPAIR THE PULMONARY HEMORRHAGE WHEREAS A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU454515J/ 12552619) WAS ADDITIONALLY IMPLANTED. ALSO, A BYPASS SURGERY WAS PERFORMED FROM THE RIGHT AXILLARY ARTERY TO THE BYPASS GRAFT. THE LEFT SUBCLAVIAN ARTERY WAS COIL-EMBOLIZED. ACCORDING TO THE CRO IN (B)(6), NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724319 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8233021

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R TGT4015/8526182