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

Catalog Number	TGU343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to aneurysm enlargements.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a type b thoracic aortic dissection, zone 2 with gore® tag® thoracic branch endoprostheses and a conformable gore® tag® thoracic endoprosthesis as distal extension to aortic component.The maximum aortic diameter in the treatment zone was 44.6mm.According to the report all devices were positioned and implanted without issue.On (b)(6) 2018 the maximum aortic diameter in the treated segment was 47mm.On (b)(6) 2019 the maximum aortic diameter in the treated segment was 50.9mm.On (b)(6) 2019 distal aortic false lumen perfusion was noted.On (b)(6) 2019 a reintervention took place whereby the distal treatment zone was extended with another device.
Event or Problem Description
The following information was reported to gore: on (b)(6), 2018 a patient was undergoing treatment of a type b thoracic aortic dissection, zone 2 with gore® tag® thoracic branch endoprostheses and a conformable gore® tag® thoracic endoprosthesis as distal extension to aortic component.The maximum aortic diameter in the treatment zone was 44.6mm.According to the report all devices were positioned and implanted without issue.On (b)(6), 2018 the maximum aortic diameter in the treated segment was 47mm.On (b)(6), 2019 the maximum aortic diameter in the treated segment was 50.9mm on (b)(6), 2019 distal aortic false lumen perfusion was noted.On (b)(6), 2019 a reintervention took place whereby the distal treatment zone was extended with a zenith thoracic endovascular graft 38 x 1117mm (model/cat # g35357 / lot # e3813611) manufacturer: cook-aortic.The reintervention had a successful outcome.
Additional Manufacturer Narrative
B.5.Updated.

• 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: 8761500
• Report Number: 2017233-2019-00500
• Device Sequence Number: 13873125
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/05/2019

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: 01/16/2021
• Device Catalogue Number: TGU343420
• Device Lot Number: 17764518
• 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: 07/03/2019
• Supplement Report FDA Received Date: 07/28/2019
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91