BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5463685 · Received February 26, 2016

    Report

    Report Number
    2017233-2016-00167
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    April 25, 2012
    Report Date
    January 27, 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. ADDITIONAL DEVICE INVOLVED: TGT3420/9022172. (B)(4).

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: AKIRA KATAYAMA, ET AL. "REPAIR OF STENT GRAFT-INDUCED RETROGRADE TYPE A AORTIC DISSECTION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR." JAPANESE JOURNAL OF CARDIOVASCULAR SURGERY 01/2015; 44(3):133-136. ON (B)(6) 2012, A PATIENT PRESENTED WITH DILATATION OF THE DISTAL AORTIC ARCH DUE TO CHRONIC TYPE B AORTIC DISSECTION. SHE UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) IN ZONE 2 WITH GORE® TAG® THORACIC ENDOPROSTHESES (TGT4015/8861347, TGT3420/9022172) FOR CLOSURE OF THE ENTRY SITE AT THE PROXIMAL DESCENDING AORTA. ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK; THUS TOUCH-UP BALLOONING WAS PERFORMED AT THE PROXIMAL END OF THE TGT4015. TEVAR WAS SUCCESSFULLY PERFORMED AND BLOOD FLOW IN THE FALSE LUMEN STOPPED. POSTOPERATIVELY (ON AN UNKNOWN DATE), THE PATIENT DEVELOPED PARAPARESIS AND SPINAL DRAINAGE WAS PERFORMED. ON (B)(6) 2012, A RIGHT SUBCLAVIAN ARTERY TO LEFT SUBCLAVIAN ARTERY BYPASS SURGERY WAS PERFORMED TO RESTORE BLOOD FLOW TO COLLATERAL VESSELS TO SPINE. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR REHABILITATION. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYNCOPE. CT SCAN REVEALED TYPE A AORTIC DISSECTION, AND EMERGENCY SURGERY WAS PERFORMED. THE ENTRY WAS IDENTIFIED AT THE PROXIMAL EDGE OF THE PROXIMAL DEVICE (TGT4015) AND ASCENDING AORTIC REPLACEMENT WAS PERFORMED WITH PRESERVATION OF THE DEVICES. NO COMPLICATIONS WERE REPORTED AFTER THE OPEN SURGERY. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO A REHABILITATION HOSPITAL. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT EXPIRED DUE TO CEREBRAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120819 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8861347

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R