BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 16181842 · Received January 17, 2023

    Report

    Report Number
    2017233-2023-03647
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 27, 2022
    Report Date
    July 3, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 97.7 CM. THIS IS SIGNIFICANTLY SHORTER THAN THE APPROXIMATELY 156 CM MEASURED FROM A SEPARATE FULLY DEPLOYED SECONDARY SLEEVE ON A 34X34X15 DEVICE. THE CORE AND OUTER WRAP OF THE FIBER END ARE INDICATIVE OF A CLEAN CUT. THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE BREAKING, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE UNSUCCESSFULLY DEPLOYING FOLLOWING SECONDARY DEPLOYMENT. SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO BEING CUT. THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. WITH THE INFORMATION REPORTED TO GORE THIS INVESTIGATION IS CONSIDERED COMPLETE, THE CAUSE OF THE COMPLAINT WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. CONCOMITANT MEDICAL DEVICE: GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® DRYSEAL FLEX INTRODUCER SHEATH 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 REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM AND WAS TREATED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. AFTER POSITIONING, THE PHYSICIAN PULLED THE SECONDARY DEPLOYMENT HANDLE. DEPLOYMENT WAS UNSUCCESSFUL. UPON INSPECTION, THE SECONDARY DEPLOYMENT LINE WAS NOT PRESENT UNDER THE ACCESS HATCH. THE SECONDARY DEPLOYMENT LINE ON THE HANDLE APPEARED SHORTER THAN USUAL. THE LOCKWIRE HANDLE AND ANGULATION ASSEMBLY HANDLES WERE THEN USED, BUT 100% DEPLOYMENT WAS STILL UNSUCCESSFUL. A COOK MEDICAL CODA BALLOON WAS DEPLOYED INSIDE THE ENDOPROSTHESIS AND WAS EXPANDED TO DEPLOY THE DEVICE. DEPLOYMENT WAS SUCCESSFUL. POSITIONING WAS NOT EXACT BUT CT IMAGING CONFIRMED SUCCESSFUL EXCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM AND WAS TREATED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. AFTER POSITIONING THE ENDOPROSTHESIS, THE PHYSICIAN PULLED THE PRIMARY DEPLOYMENT HANDLE. DEPLOYMENT WAS UNSUCCESSFUL. UPON INSPECTION, THE PRIMARY DEPLOYMENT WIRE WAS NOT PRESENT UNDER THE ACCESS HATCH. THE BACKUP DEPLOYMENT WIRE APPEARED SHORTER THAN USUAL AND ALSO DID NOT SUCCESSFULLY DEPLOY THE DEVICE. A COOK MEDICAL CODA WAS DEPLOYED INSIDE THE ENDOPROSTHESIS AND WAS EXPANDED TO SUCCESSFULLY DEPLOY THE DEVICE. POSITIONING WAS NOT EXACT BUT CT IMAGING CONFIRMED EXCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657436 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other SEE H10