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

Model Number	TGT4020
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: additional device implanted in 2013 - tgt3420/(b)(4).According to the gore® tag® thoracic endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2013, the patient underwent total debranching tevar of the aortic arch using gore® tag® thoracic endoprostheses.On an unknown date, an unknown type endoleak was observed.On (b)(6) 2020, a re-intervention was performed.The intra-operative angiography imaging revealed a proximal type i endoleak.Two additional stent grafts were placed to reline the tag® devices that were initially placed.No endoleak was observed on the final angiography imaging, and the procedure was completed.The patient tolerated the procedure.

• Brand Name: GORE TAG THORACIC ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10643262
• Report Number: 2017233-2020-01334
• Device Sequence Number: 3054706
• Product Code: MIH
• UDI-Device Identifier: 00733132613717
• UDI-Public: 00733132613717
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: 07/31/2015
• Device Model Number: TGT4020
• Device Catalogue Number: TGT4020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: 89 YR