BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 8663060 · Received June 3, 2019

    Report

    Report Number
    2017233-2019-00383
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 23, 2019
    Report Date
    July 29, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132618194
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE 4116: THE DEVICE DELIVERY CATHETER AND DETACHED LEADING OLIVE WERE RETURNED TO GORE AND AN ENGINEERING EVALUATION SHOWED THE FOLLOWING: APPROXIMATELY 39.5MM OF THE DUAL LUMEN COMPONENT OF THE CATHETER AND LEADING OLIVE BROKE OFF FROM THE LEADING END OF THE CATHETER. THE STIFFENING WIRE REMAINED WITH THE LARGE PORTION OF THE DELIVERY CATHETER. THE BREAK PATTERN ON THE DELIVERY CATHETER PORTION IS CONSISTENT WITH WHAT IS EXPECTED FOR A TENSILE BREAK. THERE IS DAMAGE TO THE OLIVE AND DUAL LUMEN. THE FINDINGS OF THE EVALUATION ARE CONSISTENT WITH THE PHYSICIAN¿S OBSERVATION THAT THE TIP OF THE CATHETER (DUAL LUMEN AND OLIVE) BROKE OFF OF THE DELIVERY CATHETER. THE ROOT CAUSE FOR THE DUAL LUMEN BREAKING AND CAUSING THE TIP OF THE CATHETER AND LEADING OLIVE TO SEPARATE FROM THE DELIVERY CATHETER IS A TENSILE BREAK DUE TO RESISTIVE FORCE. H6: CODE 18: THE WARNINGS AND PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) CLEARLY STATES, ¿DO NOT CONTINUE ADVANCEMENT OR RETRACTION OF THE GUIDEWIRE, SHEATH, OR DELIVERY CATHETER IF RESISTANCE IS FELT. STOP AND ASSESS THE CAUSE OF RESISTANCE. VESSEL, ENDOPROSTHESIS, OR DELIVERY CATHETER DAMAGE MAY OCCUR.¿

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. A 22 FR. GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ADVANCEMENT OF THE DEVICE ALONG SIDE A PIG TAIL CATHETER. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND WHEN WITHDRAWING THE DELIVERY CATHETER, THE OLIVE TIP BECAME WRAPPED AROUND THE PIG TAIL CATHETER AND GOT STUCK ON THE VALVE OF THE SHEATH. IT WAS REPORTED BY THE PHYSICIAN THAT HE PULLED BACK ¿HARD¿ ON THE DELIVER CATHETER, CAUSING THE TIP TO BREAK OFF INSIDE THE SHEATH AND CAUSING DAMAGE TO THE VALVE OF THE SHEATH. THE DELIVERY CATHETER, WITH THE DETACHED OLIVE TIP WERE ALL REMOVED TOGETHER WITH THE SHEATH. A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED 2 UNITS OF BLOOD DUE TO THE UNPLANNED SHEATH REMOVAL. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THERE WAS NO PROBLEM WITH ANY OF THE GORE DEVICES; NOT REMOVING THE PIGTAIL CATHETER PRIOR TO REMOVAL OF THE DELIVERY CATHETER HAD BEEN THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456581 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20571697 00733132618194

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR