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

Catalog Number	TGU212110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2018, the patient underwent endovascular treatment of a coarctation of the thoracic aorta and a descending thoracic aortic dissection with gore® tag® thoracic branch endoprosthesis (tgu212110/16460122).It was reported the patient had a fever prior to the implant procedure.The patient tolerated the procedure.On (b)(6) 2018, the patient underwent treatment for a pseudoaneurysm distal to the implanted gore® tag® thoracic branch endoprosthesis.There was a possible infection still present.The physician implanted an additional gore® tag® thoracic branch endoprosthesis (thu212110/16576646a).The patient tolerated the procedure.The physician is taking a wait and watch approach for the possible infection.

• 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: 7713157
• Report Number: 2017233-2018-00411
• Device Sequence Number: 11016758
• Product Code: MIH
• UDI-Device Identifier: 00733132617777
• UDI-Public: 00733132617777
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: 06/15/2020
• Device Catalogue Number: TGU212110
• Device Lot Number: 16460122
• 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: 07/23/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ASPIRIN
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 29 YR
• Patient Weight: 87