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

Catalog Number	TGU373715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Claudication (2550)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown which device caused this adverse event so all devices are being included on this report.Additional devices include: item #tgu373715/lot #20566741/udi # (b)(4).The review of the manufacturing paperwork verified that the lots met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, neurologic damage, local or systemic (e.G.Stroke, paraplegia, paraparesis), and peripheral malperfusion or ischemia.Furthermore, the conformable gore® tag® thoracic endoprosthesis ifu warns that excessive thrombus or atherosclerotic plaque in the aortic arch may increase the risk of stroke secondary to the implantation procedure.When covering the left subclavian artery ostium without revascularization (e.G.Transposition or bypass), users are made aware that there may be an increased risk of stroke due to decreased flow in the left vertebral artery.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular repair of a thoracic aortic aneurysm using two conformable gore® tag® thoracic endoprostheses.It was reported that the treatment range extended to the patient's brachiocephalic artery.The patient's left subclavian artery was plugged.Calcification was noted in the patient's aortic arch.Reportedly the procedure was successful.No endoleaks were noted.The patient tolerated the procedure.On (b)(6) 2019 the patient presented with left leg weakness.The patient was coherent with no reported cognitive issues.A potential stroke was suspected.An mri confirmed that the patient suffered minor strokes reportedly related to manipulation in the aortic arch during the procedure.The patient had continuing moderate left leg weakness following the mri.On (b)(6) 2019 it was reported that the patient was discharged with full neurological recovery.

• 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: 8733164
• Report Number: 2017233-2019-00462
• Device Sequence Number: 2271502
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 03/07/2022
• Device Catalogue Number: TGU373715
• Device Lot Number: 20585473
• 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: 06/25/2019
• 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; Life Threatening; Other
• Patient Age: 76 YR