BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16727871 · Received April 12, 2023

    Report

    Report Number
    2017233-2023-03859
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 18, 2023
    Report Date
    June 2, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646951
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: (B)(4); UDI: (B)(4). 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

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: IT WAS REPORTED THAT THE PHYSICIAN HAD TROUBLE WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS DURING DEPLOYMENT WHILE DOING AN ELEPHANT TRUNK PROCEDURE IN ZONE 0 ASCENDING AORTA. THE FIRST DEVICE, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT LOT 25480131, WAS DEPLOYED WITHOUT A WIRE AND THE PHYSICIAN ¿WAS UNABLE TO REMOVE THE RED LOCKWIRE FROM THE CATHETER. AFTER ACCESSING THE DEPLOYMENT LINE ACCESS HATCH AND CUTTING THE LOCKWIRE IN CHANNEL 3, HE WAS STILL UNABLE TO PULL THE WIRE AND REMOVE IT FROM THE CATHETER¿. AT THAT TIME, THE FSA SUGGESTED THE PHYSICIAN TO REMOVE THE ENTIRE DEVICE AND TRY ANOTHER GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. THE SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT LOT 26157550, DURING DEPLOYING IT OVER AN AMPLATZ WIRE. THERE WAS NO ISSUE WITH THE FIRST TWO STEPS OF DEPLOYMENT, WHEN THE PHYSICIAN WENT TO RELEASE THE RED LOCKWIRE FROM THE CATHETER, IT ONCE AGAIN WOULD NOT RELEASE. HE ACCESSED THE HATCH AND CUT THE WIRE IN CHANNEL 3, HOWEVER COULD STILL NOT REMOVE THE WIRE. AT THIS POINT, THE FSA SUGGESTED CUTTING THE CATHETER DISTAL TO THE OLIVE TIP TO RELEASE THE GRAFT. THE PHYSICIAN DID SO, THE GRAFT RELEASED, AND HE RETRIEVED THE OLIVE TIP. THE PHYSICIAN CONTINUED WITH THE SURGERY AND THERE WERE NOT ANY OTHER ADVERSE EVENTS WITH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022272 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGM343410 00733132646951

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization