MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGT3715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.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
The following was reported to gore: on (b)(6) 2011, the patient underwent endovascular repair of a thoracic aortic aneurysm using a gore® tag® thoracic endoprosthesis.The patient tolerated the procedure.On (b)(6) 2011, the maximum diameter of the aneurysm was 50 mm.On (b)(6) 2011, the maximum diameter of the aneurysm was 50 mm.On (b)(6) 2012, the maximum diameter of the aneurysm was 48 mm.On (b)(6) 2013, the maximum diameter of the aneurysm was 43 mm.On (b)(6) 2014, the maximum diameter of the aneurysm was 48 mm.On (b)(6) 2015, the maximum diameter of the aneurysm was 45 mm.On (b)(6) 2016, the maximum diameter of the aneurysm was 45 mm.On (b)(6) 2019, an impending rupture was observed due to a type 1a and 1b endoleak.Two conformable gore® tag® thoracic endoprostheses were implanted to extend both proximally and distally of the original implanted gore® tag® thoracic endoprosthesis.Imaging identified that the type 1b endoleak remained.Ballooning was then performed to repair the type 1b endoleak.Final imaging showed the endoleak remained slightly, but at this time the physician decided to monitor it.The patient reportedly tolerated the procedure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8916455
• Report Number: 2017233-2019-00688
• Device Sequence Number: 16832502
• Product Code: MIH
• UDI-Device Identifier: 00733132613670
• UDI-Public: 00733132613670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 12/31/2013
• Device Catalogue Number: TGT3715
• Device Lot Number: 8749832
• 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: 08/21/2019
• 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: 83 YR