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

Model Number	TGU454520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: hydrocodone-acetaminophen 5-325mg, losartan 25mg, ativan 0.5mg, metoprolol-succinate 50mg, tramadol 50mg, aspirin 81mg, lasix 20mg, lipitor 20mg.The device remains implanted, so evaluation of the actual device was unable to be completed.Images were provided, and an imaging evaluation was performed.Review of the manufacturing paperwork verified that the lot met all pre-release specifications.The imaging evaluation stated the following: centerline reconstruction illustrating what appears to be about 6mm of distal seal.Centerline reconstruction illustrating what appears to be contrast pooling outside of the device.Axial image illustrating lack of wall apposition.Axial image illustrating what appears to be contrast pooling outside of the device.Centerline reconstruction illustrating what appears to be 9.2cm of length from the distal aspect of the device to the celiac artery.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, endoleak and reoperation.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular treatment using a conformable gore® tag® thoracic endoprosthesis.On (b)(6) 2020 ct scan identification of a distal type i endoleak was reported.No aneurysm enlargement was reported.On (b)(6) 2020 a reintervention was performed.A gore® tag® conformable thoracic stent graft with active control system was placed to treat the distal type i endoleak.The procedure was reportedly successful.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: 9788001
• Report Number: 2017233-2020-00146
• Device Sequence Number: 13579089
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 12/18/2021
• Device Model Number: TGU454520
• Device Catalogue Number: TGU454520
• Device Lot Number: 20302885
• 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: 03/04/2020
• 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: Required Intervention
• Patient Age: 85 YR