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

Catalog Number	TGU454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is not known which device if any were involved in the endoleaks, therefore both devices are being investigated.Concomitant medical products: additional device: tgu454520, lot# 18488254, udi information: (b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient underwent treatment of a thoracic aortic aneurysm, measuring 64mm, in zone 0, with gore® tag® thoracic branch endoprostheses and two conformable gore® tag® thoracic endoprostheses as distal extension to the aortic component.A gore® dryseal flex sheath was utilized for access.According to the report all devices were positioned and implanted without issue.On (b)(6) 2018 a type iii endoleak was discovered.On (b)(6) 2018 a type ii endoleak was discovered.The maximum aortic diameter was 69mm.The event is ongoing.

• 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: 8243027
• Report Number: 2017233-2019-00027
• Device Sequence Number: 2322162
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 06/20/2021
• Device Catalogue Number: TGU454520
• Device Lot Number: 18488255
• 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: 01/13/2019
• 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; Other
• Patient Age: 70 YR
• Patient Weight: 71