BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 14310714 · Received May 6, 2022

    Report

    Report Number
    2017233-2022-02907
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 12, 2022
    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

    THE FOLLOWING INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED ¿ WEIGHT, DATE OF BIRTH AND MEDICATIONS PATIENT¿S PRE-EXISTING CONDITIONS INCLUDE - THORACOSCOPIC LUNG RESECTION. THE EVENT DATE WAS NOT IDENTIFIED. THE DATE OF THE SURGICAL REINTERVENTION PROCEDURE WAS USED AS THE EVENT DATE. (B)(4). PER THE INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO: DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL & SURROUNDING VASCULATURE.

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6: COMPONENT CODE.

    Additional Manufacturer Narrative · 0

    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. G3/G4 DATE RECEIVED BY MANUFACTURER 10-MAY-2022 ¿ MANUFACTURING RECORD REVIEW WAS COMPLETED IN FULL ON THIS DATE. H6: CODE 213, NO DEVICE PROBLEM FOUND ¿ A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE 22, KNOWN INHERENT RISK OF DEVICE - ACCORDING TO THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) WARNINGS AND PRECAUTIONS: INTERVENTION OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING AORTAS, ENDOLEAKS, DISSECTION EXTENSION, OR PERSISTENT FALSE LUMEN PERFUSION. AN INCREASE IN AORTIC DIAMETER, PERSISTENT ENDOLEAK, OR CONTINUED FALSE LUMEN PERFUSION MAY LEAD TO AORTIC RUPTURE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2017, THIS PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) FOR A THROMBOTIC OCCLUSION RETROGRADE TYPE B AORTIC DISSECTION. ON AN UNKNOWN DATE, AORTIC VALVE AND ASCENDING AORTA ENLARGEMENT WERE CONFIRMED (5001-C:-UNKNOWN). A SLIGHT NEW AORTIC DISSECTION (P-SINE) WAS OBSERVED ON THE LESSER CURVATURE SIDE OF CTAG. ON (B)(6) 2022, THE PATIENT UNDERWENT TOTAL AORTIC REPLACEMENT (TAR), BENTALL PROCEDURE, AND OPEN STENT PLACEMENT. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION. AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO BRIDGE THE OPEN STENT AND CTAG. THE PHYSICIAN STATED THE FOLLOWING: ALTHOUGH THE P-SINE WAS SLIGHT, ASCENDING AORTA AND AORTIC VALVE ENLARGEMENT WERE ALSO OBSERVED, SO THIS REOPERATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214846 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| R| O