BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3911291 · Received July 2, 2014

    Report

    Report Number
    2017233-2014-00348
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    November 28, 2012
    Report Date
    June 21, 2014
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A CHRONIC STANFORD TYPE B DISSECTION OF THORACIC AORTA USING GORE TAG THORACIC ENDOPROSTHESIS. DISSECTION EXPANDED FROM THE DISTAL AORTIC ARCH TO THE LEFT COMMON ILIAC ARTERY, AND THE ENLARGEMENT AND DEFORMATION OF THE DISTAL AORTIC ARCH WERE REVEALED. BEFORE A STENT GRAFT WAS IMPLANTED, THE PHYSICIAN CONSTRUCTED A TOTAL DEBRANCHING OF THE GRAFT IN THE ASCENDING AORTA TO ALL THE BRANCH ARTERIES IN THE AORTIC ARCH. A STENT GRAFT WAS THEN DEPLOYED IN THE POSITION WHERE ALL THE BRANCH ARTERIES WERE INTENTIONALLY COVERED. THE PHYSICIAN CONCLUDED THE PROCEDURE, AND THE PATIENT'S CONSCIOUSNESS WAS CLEAR POST PROCEDURE AND NO PARAPLEGIA WAS REVEALED. ON (B)(6) 2012, THE PATIENT DEVELOPED PARAPLEGIA. A SPINAL DRAINAGE WAS PERFORMED AND MEDICATIONS (NALOXONE AND METHYLPREDNISOLONE) WERE ADMINISTERED TO TREAT THE PARAPLEGIA, BUT IT WAS NOT RESOLVED. A CT DID NOT REVEAL AN ENDOLEAK. AN MRI SHOWED THAT NEURODEGENERATION WAS PRESENT IN THE LEVEL OF OR LOWER THAN THE PATIENT'S SEVENTH OR EIGHTH THORACIC VERTEBRATE. THE PATIENT ALSO STARTED A REHABILITATION THERAPY, AND SHE WAS LATER DISCHARGED IN HER WHEELCHAIR. THE PATIENT'S CONDITION HAD BEEN ASSESSED IN HER FOLLOW-UP VISITS, AND A CT REVEALED THAT THE BLOOD FLOW INTO THE FALSE LUMEN WAS EXCLUDED AND THAT THE FALSE LUMEN AREA WAS GETTING EVEN SMALLER. PER THE PHYSICIAN'S COMMENT, THE PATIENT HAD AN ACUTE THORACIC AORTIC DISSECTION PRIOR TO THE PROCEDURE, AND A NEW DISSECTION OCCURRED, ORIGINATING FROM THE RE-ENTRY SPACE OF THE PREVIOUS DISSECTION. THE NEW DISSECTION WAS EXPANDED TO THE RENAL ARTERY WITHOUT ANY RE-ENTRY SPACE, AND THE PHYSICIAN DECIDED TO PERFORM AN ENDOVASCULAR TREATMENT USING STENT GRAFTS TO COVER THE ENTRY SPACE. THE BLOOD FLOW TO THE FALSE LUMEN WAS EXCLUDED AFTER THE PROCEDURE AND IT WAS GETTING EMBOLIZED. THE PATIENT DEVELOPED THE PARAPLEGIA 1 DAY POST PROCEDURE, AND SPINAL DRAINAGE, MEDICATIONS AND BLOOD PRESSURE CONTROL (MAINTAINED AT 90-100 MMHG) WERE PERFORMED. HOWEVER, THE PARAPLEGIA WAS NOT RESOLVED AND THE PHYSICIAN STOPPED SPINAL DRAINAGE 6 DAYS POST PROCEDURE, AND THE PATIENT WAS DISCHARGED WITH PARAPLEGIA STILL REMAINED 44 DAYS POST PROCEDURE. PER REPORT, AFTER THE BLOOD FLOW TO THE FALSE LUMEN WAS EXCLUDED BY THE STENT GRAFT IMPLANTED, SOME OF THE INTERCOSTAL ARTERIES, ORIGINATING FROM THE FALSE LUMEN, GOT EMBOLIZED, WHICH MAY HAVE REDUCED THE BLOOD FLOW TO THE SPINE AND CAUSED THE PARAPLEGIA. AN MRI REVEALED THAT NEURODEGENERATION WAS PRESENT IN THE LEVEL OF OR LOWER THAN THE PATIENT'S SEVENTH OR EIGHTH THORACIC VERTEBRATE. ALSO, THE THORACIC ARTERY WAS TREATED WITH THE STENT GRAFTS FROM THE AORTIC ARCH TO THE FIFTH OR SIXTH VERTEBRATE. IMPLANTATION OF THE STENT GRAFTS WAS PERFORMED WITHOUT ANY ISSUE, BUT THE BLOOD FLOW TO THE FALSE LUMEN WAS EXCLUDED AND IT BECAME EMBOLIZED, CAUSING THE PARAPLEGIA PROTRACTEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385723 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10597005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S TGT3415/10442320