BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 12450647 · Received September 9, 2021

    Report

    Report Number
    2017233-2021-02355
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    December 13, 2018
    Report Date
    January 12, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDED COMPONENT CODE.

    Additional Manufacturer Narrative · 0

    H6-CODE 4111: REQUEST WAS EMAILED TO THE CORRESPONDING AUTHOR TO PROVIDE ADDITIONAL INFORMATION LIKE SERIAL NUMBERS, PATIENT IDENTIFIERS, DATE OF BIRTH, AGE, WEIGHT, GENDER, NAME, DATE OF IMPLANTATIONS, ONSET DATE OF THE EVENTS, DESCRIPTION OF RELATED PROCEDURES AND INTRA- AND POSTPROCEDURAL DICOM ANGIOGRAPHY IMAGING SERIES. THE CORRESPONDING AUTHOR THAT HE IS UNABLE TO RESPOND TO THE REQUESTS DUE TO DATA PROTECTION LAWS AND HIS TEAM'S HEAVY WORKLOAD. H6-CODE 4117: THE DEVICES REMAINS IMPLANTED IN THE PATIENTS. THEREFORE DEVICE EVALUATIONS COULD NOT BE PERFORMED. H6-CODE 4119: THE SERIAL NUMBERS OF THE DEVICES REMAINS UNKNOWN. THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. H6-3221: THE REPORTED EVENTS WAS UNABLE TO BE CONFIRMED WITH THE INFORMATION AVAILABLE. THE ROOT CAUSE FOR THE REPORTED POST-DEPLOYMENT MIGRATIONS COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. IN TOTAL FIVE (5) MANUFACTURER REPORT RELATED TO THE REVIEWED ARTICLE ARE BEING SUBMITTED TO FDA: 2017233-2021-02347, 2017233-2021-02352, 2017233-2021-02354, 2017233-2021-02355, 2017233-2021-02362.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ARTICLE WAS REVIEWED "ENDOGRAFT MIGRATION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR" PHILIPP GEISBÜSCH ET AL J VASC SURG. 2019 MAY;69(5):1387-1394 DOI: 10.1016/J.JVS.2018.07.073 EPUB 2018 DEC 13. PATIENT IDENTIFIER REMAINS UNKNOWN, THEREFORE THE GORE CASE REFERENCE NUMBER WAS USED. PATIENT AGE WAS NOT GIVEN WITHIN THE LITERATURE, THEREFOR THE MEAN AGE OF THE MIGRATION GROUP WAS USED PATIENT GENDER: VAST MAJORITY OF THE MIGRATION GROUP WAS MALE DATE OF THE EVENT REMAINS UNKNOWN, THEREFORE THE DATE THE ARTICLE WAS FIRST PUBLISHED WAS USED. IN TOTAL 5 MEDWATCH REPORTS RELATED TO THE REVIEWED ARTICLE ARE BEING SUBMITTED TO FDA. ALL REPORTS REFER TO THE SAME PATIENT IDENTIFIER, WHICH IS THE GORE REFERENCE NUMBER. THE MANUFACTURER REPORT NUMBERS ARE NOT AVAILABLE AT THE TIME OF SUBMISSION. A REQUEST WAS EMAILED TO THE CORRESPONDING AUTHOR TO PROVIDE ADDITIONAL INFORMATION LIKE SERIAL NUMBERS, PATIENT IDENTIFIERS, DATE OF BIRTH, AGE, WEIGHT, GENDER, NAME, DATE OF IMPLANTATIONS, ONSET DATE OF THE EVENTS, DESCRIPTION OF RELATED PROCEDURES AND INTRA- AND POSTPROCEDURAL DICOM ANGIOGRAPHY IMAGING SERIES. THE DEVICES REMAINS IMPLANTED IN THE PATIENTS. THEREFORE DEVICE EVALUATIONS COULD NOT BE PERFORMED. THE SERIAL NUMBERS OF THE DEVICES REMAINS UNKNOWN. THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED "ENDOGRAFT MIGRATION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR" PHILIPP GEISBÜSCH ET AL J VASC SURG. 2019 MAY;69(5):1387-1394 DOI: 10.1016/J.JVS.2018.07.073 EPUB 2018 DEC 13. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE INCIDENCE, TIMING, AND POTENTIAL RISK FACTORS OF LATE ENDOGRAFT MIGRATION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). A RETROSPECTIVE ANALYSIS WAS CONDUCTED OF 123 PATIENTS RECEIVING TEVAR WITH THORACIC ENDOGRAFTS FROM DIFFERENT MANUFACTURERS FOR VARIOUS INDICATIONS BETWEEN JANUARY 2005 AND DECEMBER 2015. REPORTEDLY, MIGRATION OF THORACIC ENDOGRAFTS OCCURRED IN NINE PATIENTS. THE ABSOLUTE DISTANCE OF MIGRATION VARIED BETWEEN 1.0 CM TO 3.5 CM. IN THE LITERATURE THE FOLLOWING OUTCOMES RELATED TO GORE MEDICAL DEVICES WERE REPORTED IN TABLE IV: CASE 9: THE PATIENT PRESENTED WITH CHRONICALLY EXPANDED AORTIC DISSECTION WHICH WAS TREATED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS. 22 MONTHS AFTER TEVAR DEVICE MIGRATION OCCURRED AT THE DISTAL LANDING ZONE. NO ENDOLEAK WAS OBSERVED. NO REINTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346282 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization