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

Catalog Number	TGU404020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: tgu404015/8853780 udi (b)(4).The review of the manufacturing paperwork verified that these lots met all pre-release specifications.According to the conformable gore® tag® thoracic with active control 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 endoleak.
Event or Problem Description
On (b)(6) 2013, the patient was implanted with a conformable gore® tag® thoracic endoprostheses to treat a descending thoracic aortic aneurysm.It was reported that follow-up images (modality and date is unknown) revealed the patient developed an endoleak that was stable.It was unclear whether it was a type ii endoleak or proximal type i endoleak, at the time of discovery.The physician took a wait and watch approach.Computer tomography (ct) images dated (b)(6) 2019, revealed the aneurysm sac had enlarged significantly.Images dated (b)(6) 2017 revealed the aneurysm measured 54mm, images dated (b)(6) 2018 revealed the aneurysm measured 54.5mm, images dated (b)(6) 2019 revealed the aneurysm measured 58mm, and images dated (b)(6) 2019 revealed the aneurysm measured 69mm.An angiogram (date unknown) confirmed an endoleak.On (b)(6) 2019, the physician reintervened and successful proximal extension of the prior tevar was performed using an aortic tag thoracic endoprosthesis (ctag with active control (b)(4)) extending to the left common carotid artery.The left subclavian artery was then embolized at the same setting using a 14 mm amplatzer plug.The patient tolerated the procedure.

• 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: 9461599
• Report Number: 2017233-2019-01243
• Device Sequence Number: 11531216
• Product Code: MIH
• UDI-Device Identifier: 00733132617760
• UDI-Public: 00733132617760
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: TGU404020
• Device Lot Number: 11998289
• 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: 12/12/2019
• 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: 87 YR