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

Catalog Number	TGU262610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/20/2018
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 endoleak and aneurysm enlargement.
Event or Problem Description
The following information was reported to gore: on (b)() 2018 a patient underwent treatment of a thoracic aortic dissection, zone 2, with maximum aortic diameter of 50.2mm using two gore® tag® thoracic branch endoprostheses and one conformable gore® tag® thoracic endoprostheses as distal extension to aortic component.According to the report all devices were positioned and implanted without issue.On (b)() 2018 a ct revealed the maximum aortic diameter was 52mm.On (b)() 2018 the patient underwent an additional procedure whereby an additional device was implanted to extend the treatment.Following the procedure a thrombosis of the left external iliac and common femoral artery occurred.This was stated to be procedure related.On (b)() 2018 a thrombectomy of the left external iliac and common femoral artery was performed.It is not known why the vessels thrombosed.
Event or Problem Description
The following information was reported to gore: on (b)(6)2018 a patient underwent treatment of a thoracic aortic dissection, zone 2, with maximum aortic diameter of 50.2mm using two gore® tag® thoracic branch endoprostheses and one conformable gore® tag® thoracic endoprostheses as distal extension to aortic component.According to the report all devices were positioned and implanted without issue.On (b)(6), 2018 a ct revealed the maximum aortic diameter was 52mm.On (b)(6) 2018 the patient underwent an additional procedure whereby an additional device was implanted to extend the treatment.This was due to a descending thoracic aneurysm.Following the procedure a thrombosis of the left external iliac and common femoral artery occurred.This was stated to be procedure related.On (b)(6) 2018 a thrombectomy of the left external iliac and common femoral artery was performed.It is not known why the vessels thrombosed.On (b)(6) 2019 it was reported a gore sheath was associated with the thrombosis.This information will be reported separately.
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: 8457790
• Report Number: 2017233-2019-00178
• Device Sequence Number: 3013250
• Product Code: MIH
• UDI-Device Identifier: 00733132617784
• UDI-Public: 00733132617784
• 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): 04/02/2019

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: 07/19/2020
• Device Catalogue Number: TGU262610
• Device Lot Number: 17155306
• 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: 03/27/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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: 40 YR
• Patient Weight: 59