BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17726206 · Received September 11, 2023

    Report

    Report Number
    2017233-2023-04264
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 11, 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

    H.6.: CODE C19: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. H.6.: CODE B20: DEVICE REMAINS IMPLANTED AND THEREFORE NOT AVAILABLE FOR DIRECT ANALYSIS. H.6.: CODE A0101: USED TO CAPTURE THE PATIENT'S PROXIMAL NECK LENGTH WAS SHORT AND REVERSE TAPERED SHAPE. H.6.: CODE D12: THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL & SURROUNDING VASCULATURE. H.6.: CODE D1102: ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS OR COMPLICATIONS MAY INCLUDE, BUT ARE NOT LIMITED TO STENT GRAFT: IMPROPER PLACEMENT. 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 FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN EMERGENCY ZONE 2 TEVAR OF A THORACIC AORTIC ANEURYSM RUPTURE USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THE FIRST GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED DISTALLY. AND THEN THE SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DEPLOYED PROXIMALLY. THE SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED AT THE POSITION WHERE THE PARTIALLY UNCOVERED PROXIMAL STENT COVERED THE LEFT COMMON CAROTID ARTERY SLIGHTLY. THE FLOW OF THE LEFT COMMON CAROTID ARTERY WAS ABLE TO BE CONFIRMED. AFTERWARDS, WHEN A GUIDE WIRE WAS INSERTED INTO THE LEFT SUBCLAVIAN ARTERY TO EMBOLIZE THE LEFT SUBCLAVIAN ARTERY AS PLANNED, THE GUIDE WIRE PENETRATED THE LEFT SUBCLAVIAN ARTERY. THE COIL EMBOLIZATION WAS PERFORMED AND THE BLEEDING WAS STOPPED. A FINAL ANGIOGRAPHY REVEALED A MINOR PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN DECIDED TO MONITOR THIS ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE PROXIMAL TYPE I ENDOLEAK MIGHT HAVE OCCURRED DUE TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED FROM ZONE 2. HE ALSO SAID THAT THIS CASE SHOULD HAVE BEEN UNDERGONE ZONE 1 TEVAR WITH 2 DEBRANCH BYPASS BUT IT WAS THE EMERGENCY TEVAR, THEREFORE ZONE 2 TEVAR WITHOUT BYPASS WAS SELECTED. REPORTEDLY, A BALLOONING TO THE STENT GRAFT WAS NOT PERFORMED BECAUSE THERE WAS A RISK OF MIGRATION TO DISTALLY DUE TO THE PATIENT'S PROXIMAL NECK LENGTH WAS SHORT AND REVERSE TAPERED SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231668 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 81 YR Male Other