BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® CARDIOVASCULAR PATCH

    MDR report key: 7953385 · Received October 10, 2018

    Report

    Report Number
    2017233-2018-00605
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    June 1, 2018
    Report Date
    September 12, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DXZ
    PMA / PMN Number
    K811841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH "GORE-TEX SHEET" WAS USED IN THIS PATIENT'S THYROPLASTY PROCEDURE. THE ARTICLE MAY BE REFERENCING THE GORE-TEX® CARDIOVASCULAR PATCH WHICH IS SOLD IN JAPAN AND MAY HAVE BEEN SELECTED FOR THIS TYPE OF PROCEDURE. NO DEVICE INFORMATION WAS PROVIDED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED AND A CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. CITATION: TSURUMOTO I., IMURA J., KOJIMA H. GORE-TEX SHEET FELL OFF FROM THE THYROID CARTILAGE INTO THE TRACHEA WHEN IT PASSED MORE THAN 11 YEARS AFTER THYROPLASTY. JOURNAL OF THE SOCIETY OF PRACTICAL OTOLARYNGOLOGY, 0912-1870, VOLUME 153, PAGE 147.

    Description of Event or Problem · 1

    IN A REVIEW OF THE FOLLOWING PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: TITLE: GORE-TEX SHEET FELL OFF FROM THE THYROID CARTILAGE INTO THE TRACHEA WHEN IT PASSED MORE THAN 11 YEARS AFTER THYROPLASTY. AUTHORS: IRO TSURUMOTO, JIRO IMURA, HIROMI KOJIMA. JOURNAL: JOURNAL OF THE SOCIETY OF PRACTICAL OTOLARYNGOLOGY, 0912-1870, VOLUME 153, PAGE 147 (2018.06). IN MARCH (DATE AND YEAR UNKNOWN), THE PATIENT UNDERWENT A PROCEDURE TO RECOVER THE LEFT VOCAL CORD PARALYSIS AFTER A PROCEDURE FOR ESOPHAGEAL CANCER AT ANOTHER MEDICAL FACILITY. THE PATIENT ALLEGED THAT THE MEDIAL SHIFT OF THE VOCAL CORD HAD BEEN PERFORMED USING A GORE-TEX SHEET (THE DETAIL OF THE DEVICE IS UNKNOWN). IT WAS THOUGHT THE THYROID CARTILAGE WAS INCISED AND THE GORE-TEX SHEET WAS INSERTED THERE FOR THE MEDIAL SHIFT OF THE VOCAL CORD. IN JANUARY (DATE AND YEAR UNKNOWN BUT IT HAD PASSED MORE THAN 12 YEARS SINCE THE INITIAL PROCEDURE), THE PATIENT PRESENTED AT AN OTORHINOLARYNGOLOGY OFFICE CLOSE TO THE PATIENT¿S HOUSE WITH THE DIFFICULTY OF PROJECTING HIS VOICE. NASOPHARYNGOLARYNGOSCOPE REVEALED THAT THERE WAS A WHITE SUBSTANCE BELOW THE GLOTTIS. THEN THE PATIENT WAS TRANSFERRED FROM THE LOCAL FACILITY TO THIS MEDICAL FACILITY. AT THAT TIME, THE PATIENT COMPLAINED ABOUT DIFFICULTY OF BREATHING IN ADDITION TO THE DIFFICULTY OF PROJECTING HIS VOICE. THE REMOVAL OF THE WHITE SUBSTANCE WAS PERFORMED USING NASOPHARYNGOLARYNGOSCOPE AND A BIOPSY FORCEPS. IT WAS CONFIRMED THAT THE SUBSTANCE WAS THE GORE-TEX SHEET. THE COMPLAINED SYMPTOM RESOLVED AFTER THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794175 GORE-TEX® CARDIOVASCULAR PATCH PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R