MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU313115
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment for a type b dissection and was implanted with gore® tag® conformable thoracic stent graft in zone 3 of the thoracic aorta.The patient tolerated the procedure.On (b)(6) 2020, this patient underwent endovascular treatment for a zone one thoracic aortic arch dissection which had continued to degenerate and form a false lumen aneurysm.A frozen elephant trunk and a gore® tag® conformable thoracic stent graft were implanted and a open hybrid arch repair was performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.H6: code 18: the gore® tag® conformable thoracic stent graft provides endovascular repair of the descending thoracic aorta (dta).

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10371087
• Report Number: 2017233-2020-01087
• Device Sequence Number: 1712627
• Product Code: MIH
• UDI-Device Identifier: 00733132617814
• UDI-Public: 00733132617814
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: TGU313115
• Device Catalogue Number: TGU313115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 55 YR