BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 15443107 · Received September 17, 2022

    Report

    Report Number
    2017233-2022-03327
    Event Type
    Death
    Date Received
    September 17, 2022
    Date of Event
    October 11, 2021
    Report Date
    August 7, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ID IS UNKNOWN. A MANUFACTURER PLACEHOLDER NUMBER IS PROVIDED. INDIVIDUAL IMPLANTATION DATES ARE UNKNOWN. THE PUBLICATION DATE IS PROVIDED INSTEAD. DEVICE EVALUATED BY MFR: DEVICES NOT RETURNED FOR EVALUATION OR REMAIN IMPLANTED. THE FOLLOWING ARTICLE WAS REVIEWED: SKRYPNIK, D., BISCHOFF, M.S., MEISENBACHER, K., KRONSTEINER, D.B. AND BÖCKLER, D., 2022. A 10-YEAR SINGLE-CENTER EXPERIENCE WITH THE GORE TAG CONFORMABLE THORACIC STENT GRAFT IN THE TREATMENT OF THORACIC AORTIC DISEASE. JOURNAL OF ENDOVASCULAR THERAPY, 29(3), PP.370-380. 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.

    Additional Manufacturer Narrative · 0

    THE LOT AND SERIAL NUMBERS ARE UNKNOWN. THE DEVICES, IF EXPLANTED, HAVE NOT BEEN RETURNED AND IMAGING HAS NOT BEEN PROVIDED. THE AUTHOR STATED THAT NO MATERIAL DEGRADATION OR DEVICE OBSTRUCTIONS DURING THE MID OR LONG-TERM FOLLOW-UP. THE MIGRATIONS WERE DUE TO DISEASE PROGRESSION. ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO STENT GRAFT MIGRATION.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: SKRYPNIK, D., BISCHOFF, M.S., MEISENBACHER, K., KRONSTEINER, D.B. AND BÖCKLER, D., 2022. A 10-YEAR SINGLE-CENTER EXPERIENCE WITH THE GORE TAG CONFORMABLE THORACIC STENT GRAFT IN THE TREATMENT OF THORACIC AORTIC DISEASE. JOURNAL OF ENDOVASCULAR THERAPY, 29(3), PP.370-380. THE ARTICLE IS A SINGLE-CENTER RETROSPECTIVE STUDY DESCRIBING 194 PATIENTS PRESENTING WITH THORACIC AORTIC ANEURYSM, THORACOABDOMINAL AORTIC ANEURYSM, TYPE B AORTIC DISSECTIONS, PENETRATING AORTIC ULCER, INTRAMURAL HEMATOMA, AORTOESOPHAGEAL FISTULA, AORTOBRONCHIAL FISTULA, TRAUMATIC AORTIC RUPTURE, AND ANASTOMOTIC OR PATCH AORTIC ANEURYSM. ALL PATIENTS WERE TREATED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE FOLLOW-UP PERIOD WAS TEN YEARS. IT WAS REPORTED THE FIFTH PATIENT DESCRIBED PRESENTED WITH THORACIC AORTIC ANEURYSM. THE PATIENT PRESENTED WITH MIGRATION DUE TO DISEASE PROGRESSION CONTRIBUTING TO RUPTURE 64 MONTHS AFTER THE INTERVENTION. A REINTERVENTION WAS REJECTED. THE PATIENT DIED 81 MONTHS AFTER THE INITIAL PROCEDURE FOR UNDISCLOSED REASONS.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: SKRYPNIK, D., BISCHOFF, M.S., MEISENBACHER, K., KRONSTEINER, D.B. AND BÖCKLER, D., 2022. A 10-YEAR SINGLE-CENTER EXPERIENCE WITH THE GORE TAG CONFORMABLE THORACIC STENT GRAFT IN THE TREATMENT OF THORACIC AORTIC DISEASE. JOURNAL OF ENDOVASCULAR THERAPY, 29(3), PP.370-380. THE ARTICLE IS A SINGLE-CENTER RETROSPECTIVE STUDY DESCRIBING 194 PATIENTS PRESENTING WITH THORACIC AORTIC ANEURYSM, THORACOABDOMINAL AORTIC ANEURYSM, TYPE B AORTIC DISSECTIONS, PENETRATING AORTIC ULCER, INTRAMURAL HEMATOMA, AORTOESOPHAGEAL FISTULA, AORTOBRONCHIAL FISTULA, TRAUMATIC AORTIC RUPTURE, AND ANASTOMOTIC OR PATCH AORTIC ANEURYSM. ALL PATIENTS WERE TREATED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE FOLLOW-UP PERIOD WAS TEN YEARS. IT WAS REPORTED THE FIFTH PATIENT DESCRIBED PRESENTED WITH THORACIC AORTIC ANEURYSM. THE PATIENT PRESENTED WITH MIGRATION DUE TO DISEASE PROGRESSION CONTRIBUTING TO RUPTURE 64 MONTHS AFTER THE INTERVENTION. A REINTERVENTION WAS REJECTED. THE PATIENT DIED 81 MONTHS AFTER THE INITIAL PROCEDURE FOR UNDISCLOSED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222227 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other