MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGU343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to aneurysm enlargement and reoperation.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2017, the patient underwent treatment of a 32 cm (total treatment length) descending thoracic aortic (zone 2) dissection, distal to the left common carotid artery ostium and proximal to the left subclavian artery (lsa) with a conformable gore® tag® thoracic endoprosthesis (tgu343420/(b)(4)) and two gore® tag® thoracic branch endoprostheses (tac123420c/(b)(4) and tsb121506c/(b)(4)).According to the report, the left subclavian artery (lsa) was the intended branch vessel to be treated.On (b)(6) 2018 the thoracoabdominal aneurysm was reportedly enlarging, from chronic aneurysmal degeneration of a debakey type i dissection.On (b)(6) 2018 an abdominal aortic stent graft placement was performed to treat the enlarging thoracoabdominal aneurysm.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7632593
• Report Number: 2017233-2018-00334
• Device Sequence Number: 2281516
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 05/01/2020
• Device Catalogue Number: TGU343420
• Device Lot Number: 16359553
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 101