BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1508318 · Received September 25, 2009

    Report

    Report Number
    2017233-2009-00483
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    September 2, 2009
    Report Date
    September 24, 2009
    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

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON AN UNK DATE, A HOMEMADE STENT GRAFT WAS IMPLANTED INTO THIS PT TO REPAIR A DESCENDING THORACIC AORTIC ANEURYSM AND HAD STARTED TO KINK WHEN THE ANEURYSM SIZE DECREASED. THE PHYSICIAN DECIDED TO RELINE THE HOMEMADE STENT GRAFT. ON (B)(6), 2009, A KTI SHEATH (COOK) WAS USED IN A CONDUIT IN THE COMMON ILIAC ARTERY AND A GORE TAG THORACIC ENDOPROSTHESIS WAS DEPLOYED. ANOTHER GORE TAG THORACIC ENDOPROSTHESIS DEVICE WAS ATTEMPTED PROXIMAL TO THE FIRST DEVICE. THE PHYSICIAN DID NOT ADVANCE THE SHEATH AND WHILE POSITIONING THE SECOND GORE TAG DEVICE; THE GORE TAG DELIVERY DEVICE BECAME STUCK WHEN THE TIP OF THE DELIVERY CATHETER CAUGHT IN THE MESH OF THE HOMEMADE STENT GRAFT FRAMEWORK AT THE PROXIMAL END OF FIRST GORE TAG DEVICE. THE KTI SHEATH WAS ADVANCED INSIDE OF THE HANDMADE STENT GRAFT AND AN UNSUCCESSFUL ATTEMPTS TO PULL THE SECOND GORE TAG DEVICE BACK INTO THE SHEATH WAS MADE. AFTER MANIPULATION, THE SECOND GORE TAG DEVICE WAS DEPLOYED IN THE DESIRED LOCATION. UPON REMOVAL OF THE GORE TAG DELIVERY CATHETER, THE OLIVE TIP ALONG WITH THE ENTIRE LENGTH OF DISTAL SHAFT WIRE OF THE GORE TAG DELIVERY CATHETER WAS BROKEN AND REMAINED IN THE ACCESS VESSEL. THE WIRE WAS LOCATED IN THE EXTERNAL ILIAC ARTERY, AND THE PHYSICIAN USED A SNARE TO RETRIEVE THE WIRE AND TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG326 7001135

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R