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

Catalog Number	TGU312610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - devices also implanted on (b)(6) 2016: tgu313115/14273076, udi: (b)(4); tgu343420/15061473, udi: (b)(4); tgu343410/15080375, udi: (b)(4).According to the conformable gore® tag® thoracic endoprostheses instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and surgical conversion.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular repair of a descending thoracic aortic aneurysm using conformable gore® tag® thoracic endoprostheses.Follow up imaging dated (b)(6) 2017 showed the aneurysm measured 45 mm.Follow up imaging on an unknown date in (b)(6) 2018 showed the aneurysm measured 54 mm, however, the reason for the aneurysm growth was not reported to gore.On (b)(6) 2018, the patient underwent a conversion to open repair whereby the conformable gore® tag® thoracic endoprostheses were explanted.A cardiopulmonary bypass was also performed.

• 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: 8707868
• Report Number: 2017233-2019-00438
• Device Sequence Number: 2072928
• Product Code: MIH
• UDI-Device Identifier: 00733132618040
• UDI-Public: 00733132618040
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 05/03/2019
• Device Catalogue Number: TGU312610
• Device Lot Number: 15125848
• 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: 06/18/2019
• 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: 42 YR
• Patient Weight: 64