BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5648089 · Received May 11, 2016

    Report

    Report Number
    2017233-2016-00468
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    December 25, 2009
    Report Date
    April 11, 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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORETAGTHORACIC ENDOPROSTHESES (TG3720/06553586, TG3715/7001172). PREOPERATIVE ANEURYSM DIAMETER WAS 69 MM. AFTER THE PROCEDURE, A TYPE II ENDOLEAK WAS FOUND. THE ORIGIN WAS NOT REPORTED. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, FOLLOW-UP IMAGING SHOWED THE TYPE II ENDOLEAK REMAINED. THE DIAMETER OF THE ANEURYSM WAS 63 MM. ON (B)(6) 2010, SIX MONTH FOLLOW-UP IMAGING SHOWED THE TYPE II ENDOLEAK REMAINED. THE DIAMETER OF THE ANEURYSM WAS 63 MM. ON (B)(6) 2011, ONE YEAR FOLLOW-UP IMAGING SHOWED THE TYPE II ENDOLEAK REMAINED. THE DIAMETER OF THE ANEURYSM WAS 63 MM. ON (B)(6) 2011, TWO YEAR FOLLOW-UP IMAGING SHOWED THE TYPE II ENDOLEAK REMAINED, AND THERE WAS ALSO A PROXIMAL TYPE I ENDOLEAK. THE DIAMETER OF THE ANEURYSM WAS ENLARGED TO 77 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2012, FOLLOW-UP ANGIOGRAPHY WAS PERFORMED TO CHECK THE TYPE II ENDOLEAK. AFTER THE ANGIOGRAPHY, THE PATIENT DEVELOPED A CEREBRAL INFARCTION, SO MEDICAL THERAPY AND REHABILITATION WAS STARTED. ON (B)(6) 2012, A GORETAGTHORACIC ENDOPROSTHESIS (TGT3710/7735873) WAS ADDITIONALLY IMPLANTED TO REPAIR THE PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT. THE PHYSICIAN PLANNED TO COVER LEFT COMMON CAROTID ARTERY AND LEFT SUBCLAVIAN ARTERY, SO BYPASS SURGERY (2 DEBRANCHING) WAS PERFORMED BEFORE THE PROCEDURE TO MAINTAIN BLOOD FLOW OF THESE ARTERIES. COIL EMBOLIZATION OF LEFT COMMON CAROTID ARTERY AND LEFT SUBCLAVIAN ARTERY WAS ALSO PERFORMED TO PREVENT TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE PATIENT DEVELOPED ATRIAL FIBRILLATION ON THE SAME DAY, AND IT WAS CONVERTED TO SINUS RHYTHM BY COUNTERSHOCK. ON (B)(6) 2012, FOLLOW-UP IMAGING SHOWED THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. ON (B)(6) 2012, THREE YEAR FOLLOW-UP IMAGING SHOWED THE TYPE II ENDOLEAK REMAINED. THE CEREBRAL INFARCTION ALSO REMAINED. THE DIAMETER OF THE ANEURYSM WAS 73 MM. ON (B)(6) 2013, FOUR YEAR FOLLOW-UP IMAGING SHOWED THE TYPE II ENDOLEAK REMAINED. THE CEREBRAL INFARCTION WAS RESOLVED. THE DIAMETER OF THE ANEURYSM WAS 73 MM, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303460 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7001172

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R