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	TGMR312610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore through the (b)(6) clinical study.On (b)(6) 2021, the patient underwent endovascular treatment of a thoracic type b aortic dissection, zone 2.Gore® tag® conformable thoracic stent grafts with active control system was implanted in the distal side.Intraoperative aortography showed no specific adverse event.On (b)(6) 2021, contrast-enhanced ct showed that the false lumen proximal to the stent graft was completely thrombosed, but there was residual blood flow from the end of the stent graft to the abdominal aorta.At this point, it was unclear whether the luminal blood flow was due to re-entry flow or new entry tear.On (b)(6) 2022, non-enhanced ct showed an enlarged false-lumen diameter in the same area.So it was diagnosed that the false lumen blood flow was due to new entry tear and decided additional treatment.Treatment details is not reported.Reportedly this event originated from the distal edge of the stent graft, it is considered to be caused by ctagac and its oversizing.
Additional Manufacturer Narrative
(b)(4).
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 type b aortic dissection, zone 2.Gore® tag® conformable thoracic stent grafts with active control system was implanted in the distal side.Intraoperative aortography showed no specific adverse event.On (b)(6) 2021, contrast-enhanced ct showed that the false lumen proximal to the stent graft was completely thrombosed, but there was residual blood flow from the end of the stent graft to the abdominal aorta.At this point, it was unclear whether the luminal blood flow was due to re-entry flow or new entry tear.On (b)(6) 2022, non-enhanced ct showed an enlarged false-lumen diameter in the same area.So it was diagnosed that the false lumen blood flow was due to new entry tear and decided additional treatment.Treatment details is not reported.Reportedly this event originated from the distal edge of the stent graft, it is considered to be caused by ctagac and its oversizing.Update from april 22, 2022: on (b)(6) 2022: a reintervention was performed.Additional thoracic aortic stent graft was placed.On (b)(6) 2022: the lesion and distal sine closure was confirmed by contrast-enhanced ct.

• 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: 13556926
• Report Number: 2017233-2022-02750
• Device Sequence Number: 19787961
• Product Code: MIH
• UDI-Device Identifier: 00733132646760
• UDI-Public: 00733132646760
• 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): 05/03/2022

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: 02/09/2024
• Device Model Number: TGMR312610
• Device Catalogue Number: TGMR312610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG