MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGT3110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, this patient underwent treatment for a dissecting thoracic aortic aneurysm.A total arch replacement (tar) procedure and open stent procedure was performed, and two gore® tag® thoracic endoprostheses were implanted.The patient tolerated the procedure.On may 15, 2020, follow-up computed tomography identified a dissection from the distal end of the gore® tag® thoracic endoprosthesis and the leak from the anastomosis site of the reconstructed the left common carotid artery in the tar procedure (outside of the gore® tag® treatment area).3d reconstruction illustrating both proximal and distal false lumen profusion.3d reconstruction illustrating contrast pooling around the lsa and the lcca.3d reconstruction illustrating false lumen perfusion.On (b)(6) 2020, the patient underwent a reintervention using gore® tag® conformable thoracic stent graft with active control® system.First, a left axillary artery ¿ right axillary artery ¿ left common carotid artery bypass procedure was performed.Then, a tgmr373715j was implanted proximally of the previous implanted tag® device to solve the leak from the anastomosis site of the reconstructed left common carotid artery.Then a tgm343420j was implanted to treat the dissection.The dissection was resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
G5: completed.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10197406
• Report Number: 2017233-2020-00451
• Device Sequence Number: 3298180
• Product Code: MIH
• UDI-Device Identifier: 00733132613618
• UDI-Public: 00733132613618
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 10/31/2013
• Device Model Number: TGT3110
• Device Catalogue Number: TGT3110
• Device Lot Number: 8573269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: Required Intervention
• Patient Age: 85 YR