BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3203693 · Received June 24, 2013

    Report

    Report Number
    2017233-2013-00394
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    January 19, 2009
    Report Date
    May 28, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE, THE GORE TAG THORACIC ENDOPROSTHESIS PROVIDES ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA (DTA). AS REPORTED, THIS PT WAS TREATED FOR A PRE-EXISTING RUPTURE OF THE DTA. THE REVIEW OF THE STERILIZATION PAPERWORK VERIFIED THAT THIS ALL MET ALL PRE-RELEASE SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF A PRE-EXISTING RUPTURED THORACIC AORTIC ANEURYSM USING GORE TAG THORACIC ENDOPROSTHESIS. POST-OPERATIVE, THE PT COMPLAINED OF HYPOSTHENIA AT HIS RIGHT LOW EXTREMITY. THE PHYSICIAN SUSPECTED PARESIS DUE TO SPINAL CORD ISCHEMIA. THE PHYSICIAN ADMINISTERED MEDICATION AND STARTED THE PT ON REHABILITATION. ON AN UNKNOWN DATE, IT WAS DETERMINED THAT INFECTION OF THE STENT GRAFT WAS PRESENT. ON (B)(6) 2009, 6 MONTH FOLLOW-UP REVEALED THAT THE PARALYSIS STILL REMAINED. THE REHABILITATION CONTINUED. ON (B)(6) 2009, THE PT EXPIRED DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284882 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06247709

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| R TREATMENT OF SPINAL CORD ISCHEMIA. PT ALSO STARTED| POST-PRECEDURE: PT ADMINISTERED MEDICATION FOR| REHABILITATION.