BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 15355628 · Received September 5, 2022

    Report

    Report Number
    2017233-2022-03286
    Event Type
    Injury
    Date Received
    September 5, 2022
    Date of Event
    April 5, 2021
    Report Date
    May 26, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ID IS UNKNOWN. MANUFACTURER PLACEHOLDER PROVIDED. PATIENT MEDIAN AGE PROVIDED. MOST PREVALENT GENDER PROVIDED. DEVICES REMAIN IMPLANTED. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    MEDWATCH #2017233-2022-03286 WAS SENT IN ERROR. ADDITIONAL RECEIVED INFORMATION DETERMINED THAT THIS EVENT IS NOT REPORTABLE TO THE FDA AND THEREFORE THE MEDWATCH (AND SUPPLEMENTALS) WILL BE RETRACTED. GORE HAS ATTEMPTED TO CONTACT THE CORRESPONDING AUTHOR MULTIPLE TIMES OVER AN EXTENDED PERIOD TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. GORE IS UNABLE TO DETERMINE WHICH, IF ANY, PATIENTS EXPERIENCING SERIOUS ADVERSE EVENTS WERE TREATED WITH GORE DEVICES AS THE LITERATURE STATES MULTIPLE MEDICAL DEVICE BRANDS AND PROVIDES ONLY TOTAL NUMBERS OF PATIENT OUTCOMES.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: AMIL, C.L.B., ALOMAR, G.M., GUARNACCIA, G., LUONI, G., CASTELLNOU, X.Y., VIGLIOTTI, R.C., RAMSES, R. AND RIAMBAU, V., 2021. THE INITIAL EXPERIENCE ON BRANCHED AND FENESTRATED ENDOGRAFTS IN THE AORTIC ARCH. A SYSTEMATIC REVIEW. ANNALS OF VASCULAR SURGERY, 75, PP.29-44. IT WAS REPORTED THAT 66 PATIENTS (OUT OF 693 PATIENTS TREATED WITH GORE AND NON-GORE DEVICES) WERE TREATED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT FOR THORACIC AORTA PATHOLOGIES. PATIENT OUTCOMES WERE NOT BROKEN DOWN BY DEVICE BUT 123 PATIENTS OF THE 693 TREATED IN THE RETROSPECTIVE AND PROSPECTIVE STUDY PRESENTED WITH ENDOLEAK (36), STROKE (31), ILIAC OR SITE ACCESS BLEEDING, RUPTURE OR PSEUDOANEURYSM (23), TRANSFUSION (12), SPINAL CORD ISCHEMIA (9), DISSECTIONS (5), OPEN CONVERSIONS (3), MYOCARDIAL INFARCTION (2), LSA OCCLUSION (1) AND UNWANTED CELIAC OCCLUSION (1). ADDITIONALLY, 22 PATIENTS DIED IN THE FOLLOW-UP PERIOD (MEAN OF 18.5 MONTHS WITH A RANGE OF 0-45 MONTHS) AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458627 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other