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

Model Number	TGT3115
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2010 the patient underwent endovascular treatment of a type b thoracic aortic dissection using gore® tag® thoracic endoprostheses.On an unknown date, the follow up imaging revealed a distal stent graft induced new entry (dsine), and false lumen expansion.On (b)(6) 2020 a reintervention was performed whereby a gore® tag® conformable thoracic stent graft with active control system was implanted to treat the dsine.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: 10171950
• Report Number: 2017233-2020-01003
• Device Sequence Number: 11203124
• Product Code: MIH
• UDI-Device Identifier: 00733132613625
• UDI-Public: 00733132613625
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 06/30/2013
• Device Model Number: TGT3115
• Device Catalogue Number: TGT3115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 57