BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 10479919 · Received September 1, 2020

    Report

    Report Number
    2017233-2020-01198
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    August 8, 2020
    Report Date
    March 16, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. RESULTS CODE 2: 213: THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE EVALUATION SHOWED THE FOLLOWING: NO DAMAGE OR ANOMALIES WERE IDENTIFIED WITH THE PRIMARY AND SECONDARY DEPLOYMENT LINES (PDL AND SDL RESPECTIVELY). THE LOCKWIRE AND FERRULE WERE NOT RETURNED. A SMALL PIECE WAS BROKEN OFF THE LOCKWIRE CONNECTOR, LIKELY RESULTING IN THE LOCKWIRE BREAKING OFF THE CONNECTOR. THE ANGULATION CONNECTOR AND FIBERS WERE DISCONNECTED FROM THE ANGULATION HANDLE. THE BACK UP DEPLOYMENT MECHANISMS WAS CLOSED ON THE RETURNED DEVICE. BASED ON THE EVENT DESCRIPTION AND DEVICE EVALUATION THERE IS NO EVIDENCE THAT THE BACK UP DEPLOYMENT MECHANISM WAS USED TO COMPLETE DEPLOYMENT. BASED ON A REVIEW OF THE ARTICLE FROM PROF. P. MATT ET AL. PUBLISHED IN THE EJCTS, IT IS EXPECTED THIS DEVICE WAS DEPLOYED ANTEGRADE DURING THE HYBRID PROCEDURE. THE REPORT DESCRIPTION THAT THE PRODUCT COULD NOT RELEASE OFF THE CATHETER COULD NOT BE CONFIRMED WITH THE DEVICE EVALUATION. THE BROKEN LOCKWIRE CONNECTOR AND DISCONNECTED ANGULATION CONNECTOR AND FIBERS MAY HAVE CONTRIBUTED TO THE DIFFICULTY REMOVING THE DEVICE FROM THE DELIVER CATHETER. DURING TESTING FOR DESIGN VALIDATION, PROCESS QUALIFICATION, AND ONGOING QUALITY CONTROL TESTING, DEVICES ARE TESTED IN ANATOMICAL MODELS REPRESENTATIVE OF CMDS INDICATED USE. THERE IS POTENTIAL THAT OFF-LABEL USE IN AN ANTEGRADE HYBRID FASHION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT WAS UNDERGOING TREATMENT OF A TYPE A THORACIC DISSECTION WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. AFTER THE DEVICE WAS ADVANCED TO THE DESIRED LOCATION, DEPLOYMENT WAS ATTEMPTED. ALTHOUGH THE DEVICE FULLY EXPANDED, IT DID NOT RELEASE FROM THE DELIVERY CATHETER. PARTS OF THE DEPLOYMENT LINES BECAME SEPARATED FROM THE DEPLOYMENT HANDLE. THESE DEPLOYMENT LINE FRAGMENTS WERE THEN SURGICALLY REMOVED FROM THE PATIENT. THIS DELAYED THE PROCEDURE BY 35 ADDITIONAL MINUTES WHILE THE PATIENT WAS KEPT IN CARDIAC ARREST (CARDIAC ARREST BEING PART OF THE PLANNED PROCEDURE). THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940107 GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R