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

Catalog Number	TGU313115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: (b)(4).Additional concomitant medical products: patient medications include but are not limited to: ursodiol, atorvastin, hydrazine, hydroxyzine, iron supplement, losartan, aspirin, carvedilol, finasteride, tamsulosin, warfarin.(b)(4).
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment for a dissection of the descending thoracic aorta and was implanted with two conformable gore® tag® thoracic endoprostheses.An unknown cook device was also implanted and positioned as the most distal device.The patient tolerated the procedure.On (b)(6) 2018, the patient underwent an mri and ct of the head and neck for new onset hoarseness which showed a new large arch aneurysm which appeared to be partially thrombosed.On (b)(6) 2018, an extension of the dissection both proximally and distally was reported.Proximally the dissection had extended to the left common carotid artery (lcca) with the false lumen having extended and covering the lcca.Distally the extension extended down to the infrarenal abdominal aorta.The patient underwent reintervention and a lcca to left subclavian artery (lsa) bypass was performed and an additional conformable gore® tag® thoracic endoprosthesis was implanted proximally with coverage of the lsa and lcca.The patient tolerated the procedure.

• 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: 8066982
• Report Number: 2017233-2018-00688
• Device Sequence Number: 11438435
• Product Code: MIH
• UDI-Device Identifier: 00733132617814
• UDI-Public: 00733132617814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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: 11/30/2015
• Device Catalogue Number: TGU313115
• Device Lot Number: 10964794
• 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: 11/13/2018
• 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: 70 YR
• Patient Weight: 84