BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TRI-LOBE BALLOON CATHETER

    MDR report key: 5463702 · Received February 26, 2016

    Report

    Report Number
    3007284313-2016-00021
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    April 25, 2012
    Report Date
    March 3, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED ARTICLE.

    Additional Manufacturer Narrative · 1

    (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 USING GORE TRI-LOBE BALLOON CATHETER (BCL2645/9882035). TEVAR WAS SUCCESSFULLY PERFORMED AND BLOOD FLOW IN THE FALSE LUMEN STOPPED. 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. THE PHYSICIAN ATTRIBUTED THE FLARE OF THE TGT4015 AND BALLOONING OF THE PROXIMAL NECK TO THE CAUSE OF TYPE A DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120939 GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 9882035

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R