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

Catalog Number	TGU404010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tgu404010 udi: (b)(4), tgu404010 udi: (b)(4), tgu404010 udi: (b)(4).It is not known which of the tgu404010 devices were involved in the event, therefore all were investigated.The viabahn device is being reported separately.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2016, the patient underwent treatment of a thoracoabdominal aortic aneurysm whereby conformable gore® tag® thoracic endoprostheses and gore® viabahn® endoprostheses with heparin bioactive surface were implanted.On (b)(6) 2018 the patient exhibited a gutter leak around the left renal artery.On (b)(6) 2018 the patient's left renal artery was stented and a left renal artery branch in the gutter space was embolized.The patient tolerated the procedure.
Additional Manufacturer Narrative
Date of event.Updated event.Updated conclusion code 1: 22: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to endoleak, aneurysm enlargement and reoperation.
Event or Problem Description
The following information was reported to gore: on (b)(6)2016, the patient underwent treatment of a thoracoabdominal aortic aneurysm whereby conformable gore® tag® thoracic endoprostheses and gore® viabahn® endoprostheses with heparin bioactive surface were implanted.On (b)(6)2017 the maximum aortic diameter was 67mm.On (b)(6)2017 the maximum aortic diameter was 75mm.On (b)(6)2018 the patient exhibited a gutter leak around the left renal artery.On (b)(6)2018 the patient's left renal artery was stented and a left renal artery branch in the gutter space was embolized.The patient tolerated the procedure.On (b)(6)2018 the patient was recovering from his surgery with severe deconditioning.

• 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: 7715012
• Report Number: 2017233-2018-00422
• Device Sequence Number: 1121339
• Product Code: MIH
• UDI-Device Identifier: 00733132617739
• UDI-Public: 00733132617739
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2018

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: 08/02/2018
• Device Catalogue Number: TGU404010
• Device Lot Number: 14278707
• 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: 07/24/2018
• Supplement Report FDA Received Date: 07/24/2018; 09/03/2018
• 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: 93