MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGM343410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code "other" was selected as the medical device remains implanted.Return not possible.A severe injury, illness or impairment which requires hospitalization or medical intervention.An adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device remains implanted.The device either functioned as intended or a problem was not found.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
The following information was reported to gore through the ssb11-02 pivotal clinical study.On (b)(6) 2021, the patient underwent endovascular treatment of a thoracic aortic dissection, zone 2, using a gore® tag® conformable thoracic stent grafts with active control system.On (b)(6) 2021, it was reported type b aortic dissection.Reportedly related to device and endovascular procedure.On (b)(6) 2021, it was resolved without sequelae.Treatment details were not reported.
Additional Manufacturer Narrative
H6: code 515 ¿ tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12725627
• Report Number: 2017233-2021-02504
• Device Sequence Number: 1467839
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: TGM343410
• Device Catalogue Number: TGM343410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/31/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female