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

Catalog Number	TGU373710
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of an aneurysmal 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 pre-treatment maximum aortic diameter within the treated segment has not been recorded in the clinical study database.According to the report all devices were positioned and implanted without issue.On (b)(6) 2019 an asymptomatic, unspecified endoleak was reported.There was no aneurysm enlargement reportedly associated with the endoleak.On (b)(6) 2019 an embolization procedure was performed to address the endoleak.Following the procedure the endoleak was resolved.
Additional Manufacturer Narrative
Manufacturer report # 2017233-2019-01103 is being retracted.Additional information received indicating the endoleak was a proximal type i endoleak, which does not involve the a conformable gore® tag® thoracic endoprosthesis.

• 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: 9270517
• Report Number: 2017233-2019-01103
• Device Sequence Number: 2497930
• Product Code: MIH
• UDI-Device Identifier: 00733132617722
• UDI-Public: 00733132617722
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 01/14/2022
• Device Catalogue Number: TGU373710
• Device Lot Number: 20277857
• 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: 11/02/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: 68 YR
• Patient Weight: 102