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

Catalog Number	TGT3715
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unknown which tag device was involved with the event both devices will be include in this report.Additional device implanted: tgt3715/8538533.Lot 8538533: (b)(4).
Event or Problem Description
On (b)(6) 2011, the patient underwent treatment of a thoracic aortic aneurysm with a gore® tag® thoracic endoprosthesis.According to the report, the tag device was positioned and implanted distal to the ostium of the left common carotid artery (lcca).Intra-procedural angiography reportedly showed a proximal type i endoleak.An additional tag device was implanted for proximal extension.Final angiography, showed exclusion of the aneurysm, and no evidence of endoleak.According to the report, the patient tolerated the procedure.It was reported, routine follow-up computed tomography (ct) scans were performed until 2016 with no adverse events being reported.After 2016, the patient reportedly was lost to follow-up.On an unknown date in 2018, the patient again sought treatment and a computed tomography scan was performed.Imaging identified evidence of an aortic arch dissection proximal to the previously treated segment.According to the report, the entry tear originated from the proximal edge of the most proximal tag device.It was reported, the cause of the dissection is unknown, however, the physician stated the patient¿s fragile aorta had weaken over time due to disease progression.Reportedly, the physician plans to monitor the dissection at this time.According to the physician, all further treatments will be dependent upon the patient¿s physical ability to survive an additional procedure.

• 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: 7678224
• Report Number: 2017233-2018-00375
• Device Sequence Number: 13650414
• Product Code: MIH
• UDI-Device Identifier: 00733132613670
• UDI-Public: 00733132613670
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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: 10/31/2013
• Device Catalogue Number: TGT3715
• Device Lot Number: 8590294
• 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: 07/11/2018
• 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: Other
• Patient Age: 80 YR