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

Catalog Number	TGU454515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that these lots met all pre-release specifications.It is unknown what device has been implanted distally and both devices were investigated.Another device was involved (b)(4).According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), the gore® tag® thoracic endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing dissection extension.The safety and effectiveness of the gore® tag® thoracic endoprosthesis have not been evaluated in the following patient etiologies: chronic type b dissections.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to dissection and surgical conversion.
Event or Problem Description
On (b)(6) 2015, the patient was implanted with conformable gore® tag® thoracic endoprostheses to treat a descending aortic dissection rupture.The dissection started 5-10 cm distal to the left subclavian artery.The devices were placed in the z2 (distal to the left common carotid artery).Patient tolerated the procedure.It was reported that on (b)(6) 2018, an expanding of the chronic type b dissection from (b)(6) 2015 was identified.This chronic type b dissection led to a thoracoabdominal aneurysm and on (b)(6) 2018, the patient underwent an open repair of a thoracoabdominal aortic aneurysm using a 26mm four-branch gelweave graft and additional grafts in the iliac arteries.There was a short segment of normal aorta between the repair and the original procedure where gore devices have been used.On (b)(6) 2018, the abdominal area was washout with exploratory laparotomy, secondary abdominal closure.The patient was discharged from the hospital on (b)(6) 2018 and was doing well.On (b)(6) 2018, follow up computed tomography angiography (cta) showed that the maximum diameter of aortic aneurysm/lesion was 49mm.On (b)(6) 2018, follow up cta showed that the maximum diameter of aortic aneurysm/lesion was 48mm.It is unknown why the dissection was expanding and if it was from an entry tear outside of the area treated by a gore device or it was from a leak.

• 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: 8380208
• Report Number: 2017233-2019-00116
• Device Sequence Number: 2977688
• Product Code: MIH
• UDI-Device Identifier: 00733132618200
• UDI-Public: 00733132618200
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 04/08/2018
• Device Catalogue Number: TGU454515
• Device Lot Number: 13886352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2019
• 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; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 108