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

Catalog Number	TGU313110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to reoperation.
Event or Problem Description
On (b)(6) 2016, the patient was implanted with conformable gore® tag® thoracic branch endoprosthesis to treat a thoracic aortic aneurysm.The patient tolerated the procedure.The patient presented to the emergency room on (b)(6) 2018, with chief complaint of increasing shortness of breath and a cough.A computed tomography taken revealed a possible mycotic aneurysm (surrounding the stent graft there is increasing amorphous low density with tiny gas bubbles, overall pattern suggests possible graft infection).In addition a saccular aneurysm was present in the mid descending thoracic aorta just at the superior margin of a previously placed thoracic aortic stent graft.It was reported there is a possible thoracic graft infection and/or aorta pleural fistula.Superior to the thoracoabdominal graft there may be a saccular aneurysm.Reportedly on (b)(6) 2018, a reintervention occurred.The physician did not find an infection and treated the saccular aneurysm by implanting an additional conformable gore® tag® thoracic branch endoprosthesis to cover the saccular aneurysm.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Method code.

• 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: 7760469
• Report Number: 2017233-2018-00494
• Device Sequence Number: 16458305
• Product Code: MIH
• UDI-Device Identifier: 00733132618033
• UDI-Public: 00733132618033
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 12/31/2016
• Device Catalogue Number: TGU313110
• Device Lot Number: 12242912
• 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: 08/07/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 60