BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 17413939 · Received July 28, 2023

    Report

    Report Number
    2017233-2023-04152
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    March 1, 2023
    Report Date
    August 2, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B5 WITH ADDITIONAL INFORMATION. H6 INVESTIGATION CONCLUSION CODE CORRECTED FROM D1001-ADVERSE EVENT RELATED TO PATIENT CONDITION TO D15-CAUSE NOT ESTABLISHED.

    Additional Manufacturer Narrative · 0

    H6: CODE E2402-USED TO CAPTURE D-SINE AND SPINE FRACTURE. H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE C20 - THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. IT SHOULD BE NOTED THAT, PER THE GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, DISSECTION. 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.

    Description of Event or Problem · 0

    IT WAS ALSO REPORTED CAUSE OF SPINE FRACTURE IS UNKNOWN, AND AS PER PHYSICIAN, THE D-SINE WAS A RESULT OF THE SPINE FRACTURE. PHYSICIAN DID NOT MENTION IF THE SPINE FRACTURE OR D-SINE WAS RELATED TO PATIENT CONDITION.

    Description of Event or Problem · 0

    ON (B)(6) 2020, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A CHRONIC TYPE B AORTIC DISSECTION USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG), GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). ON AN UNKNOWN DATE ON (B)(6) 2023, THE PATIENT PRESENTED WITH A THORACIC SPINE FRACTURE AT TH9 LEVEL. THE DETAIL CT EXAMINATION CONFIRMED A DSINE (DISTAL STENT GRAFT-INDUCED NEW ENTRY) AT THE PREVIOUSLY IMPLANTED CTAG (TGU312610J) WHICH WAS PLACED AT TH9 LEVEL. THE SIGNIFICANT DEFORMATION OF PATIENTS¿ AORTA WAS ALSO NOTED. (B)(4) WAS OPENED TO ADDRESS THE FOLLOWING SHEATH LEAKAGE ISSUE). A REINTERVENTION WAS PERFORMED ON (B)(6) 2023. A 20 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (SHEATH) WAS DELIVERED FROM PATIENTS¿ RIGHT SIDE. WHEN THE SHEATH REACHED TO THE TREATMENT SITE, THE PHYSICIAN REMOVED THE DILATOR AND ADVANCED A CTAG-AC. WHEN THE STENT GRAFT PORTION JUST CAME OUT OF THE SHEATH, A BLOOD LEAKAGE FROM THE VALVE WAS OBSERVED. THE PHYSICIAN TRIED TO STOP THE LEAK BY INFLATING THE VALVE BUT WAS UNSUCCESSFUL, THEREFORE, THE CTAG-AC WAS REMOVED WITH THE SHEATH. ANOTHER SHEATH WITH THE SAME SIZE WAS USED AS A REPLACEMENT. THE CTAG-AC WAS AGAIN DELIVERED TO THE TREATMENT SITE AND WAS SUCCESSFULLY DEPLOYED. THE FINAL ANGIOGRAPHY WAS NOT PROVIDING THE CLEAR IMAGE OF THE TREATED SITE, HOWEVER, THE ENTRY TO THE FALSE LUMEN SEEMED TO HAVE DISAPPEARED AND NO ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO END THE PROCEDURE. THE PHYSICIAN PRESUMES THAT THE AORTA WAS SIGNIFICANTLY DEFORMED DUE TO THE SPINE FRACTURE AT TH9 LEVEL, AND THE DEFORMATION CAUSED THE DAMAGE OF THE VESSEL AROUND THE SAME LEVEL WHERE THE DISTAL END OF THE IMPLANTED TGU312610J WAS COINCIDENTALLY LOCATED. NO HEMODYNAMIC IMPAIRMENT OR INTRA-OPERATIVE BLOOD TRANSFUSION WAS REPORTED REGARDING THE SHEATH VALVE LEAKAGE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946034 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention