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

Model Number	TGU373710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu373720/16103179, udi (b)(4).The review of the manufacturing paperwork verified that these lots met all pre-release specifications.The conformable gore® tag® thoracic endoprosthesis instructions for use state that potential device or procedure related adverse events include endoleak and surgical conversion.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with two conformable gore® tag® thoracic endoprostheses to treat a ruptured thoracic aorta aneurysm.The patient tolerated the procedure.It was reported that images (date and modality is unknown) revealed a distal type i b endoleak.On an unknown date in (b)(6) of 2020, the devices were explanted.The devices were destroyed at the hospital.
Event or Problem Description
There was aneurysm sac enlargement (amount of enlargement is unknown).The cause of the endoleak is unknown.On (b)(6) 2020, the devices were explanted and open surgical conversion was performed.The patient tolerated the reintervention.

• 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: 9843704
• Report Number: 2017233-2020-00191
• Device Sequence Number: 14112559
• Product Code: MIH
• UDI-Device Identifier: 00733132617722
• UDI-Public: 00733132617722
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2020

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: 11/08/2021
• Device Model Number: TGU373710
• Device Catalogue Number: TGU373710
• Device Lot Number: 20071465
• 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; Not provided
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/22/2020; 04/22/2020
• 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; Required Intervention
• Patient Age: 80 YR