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

Model Number	TGT3715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, this patient endovascular treatment using gore® tag® thoracic stent graft for a chronic type b aortic dissection.On an unknown date, a possible proximal type i endoleak was observed.On (b)(6) 2021, a reintervention was performed.One debranch bypass, a left common carotid artery - left subclavian artery bypass, procedure was performed.A conformable gore® tag® thoracic endoprosthesis was implanted proximally to cover the left subclavian artery.The left subclavian artery was embolized by plug (avp2 14mm).Computed tomography angiography verified the endoleak was resolved.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: 12093821
• Report Number: 2017233-2021-02123
• Device Sequence Number: 3564755
• 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: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 07/31/2014
• Device Model Number: TGT3715
• Device Catalogue Number: TGT3715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/30/2021
• 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