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 Codes	Aneurysm (1708); Aortic Dissection (2491)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: aspirin and warfarin: a review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to aneurysm enlargement and surgical conversion.
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): 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.Reportedly, pre-implantation images taken on (b)(6) 2017, showed a maximum aortic diameter of 66.2 mm within the treatment segment.An atheroma was noted protruding > 5mm into the lumen.No significant calcium and/or thrombus at the proximal or distal implantation sites was seen on the pre-treatment images.Successful access and delivery to the intended implantation sites and retrieval of the device delivery systems was reported.Final angiography confirmed repair of the dissection, full patency of all devices and no evidence of persistent false lumen perfusion.The procedure was concluded with no reported complications and the patient tolerated the procedure.On (b)(6) 2018 it was reported the patient exhibited enlarging thoracoabdominal aortic aneurysm from chronic aneurysmal degeneration.The aneurysm measured 8cm.On (b)(6) 2018 an open type iii thoracoabdominal aortic aneurysm repair using a coselli graft and an unknown manufacturer¿s aortic bifurcated graft was performed.A left atrial to femoral bypass was also performed.On (b)(6) 2018 the maximum aortic diameter within the treated segment was 37mm.

• 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: 8145122
• Report Number: 2017233-2018-00750
• Device Sequence Number: 1961678
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 12/09/2018
• 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