BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 16908102 · Received May 10, 2023

    Report

    Report Number
    2017233-2023-03920
    Event Type
    Death
    Date Received
    May 10, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 10, 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

    H6: B20, THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION. H6: C19, A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO AORTIC EXPANSION (E .G ., ANEURYSM, FALSE LUMEN, LANDING ZONE, LESION), AORTIC RUPTURE, AND DEATH. 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

    ON (B)(6) 2021, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A DISSECTED AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON AN UNKNOWN DATE, A PROXIMAL STENT GRAFT-INDUCED NEW ENTRY (P-SINE) WAS FOUND AND AN ADDITIONAL PROCEDURE WAS INDICATED. ON (B)(6) 2023, ASCENDING AORTA-BRACHIOCEPHALIC-LEFT COMMON CAROTID ARTERIAL BYPASS WAS PLANNED TO BE CONSTRUCTED AND AN ADDITIONAL TEVAR WAS PLANNED. HOWEVER, SEVERE ABSCESS WAS FOUND WHEN THE PHYSICIAN OPENED THE PATIENT¿S CHEST. THEREFORE, THE PROCEDURE WAS CANCELLED AND THE CHEST WAS CLOSED AS IT WAS. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS REPORTED VIA THE FSA AS FOLLOWS. AFTER THE CANCELLED REINTERVENTION, A FOLLOW-UP EXAMINATION SHOWED ANEURYSM ENLARGEMENT WHICH EXCEEDED THE CTAG TREATMENT AREA. THEREFORE, THE SECOND ATTEMPT OF REINTERVENTION WAS SCHEDULED FOR (B)(6) 2023, HOWEVER, THE PATIENT DIED AT THE NIGHT BEFORE THE SCHEDULED PROCEDURE. THE CAUSE OF DEATH WAS ANEURYSMAL RUPTURE. IT WAS UNKNOWN IF THE CTAG DEVICE WAS INVOLVED IN ABSCESS AS A THORACOTOMY COULD NOT BE PERFORMED. REPORTEDLY, THE PHYSICIAN COMMENTED THAT THE PATIENT¿S CONDITION ESPECIALLY VESSEL¿S CONDITION WAS POOR AND THERE HAD ALSO BEEN A POSSIBLE RISK OF DISTAL STENT GRAFT-INDUCED NEW ENTRY (D-SINE) FOLLOWING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232258 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 Unknown Death| R| H