MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGM343410
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Paresis (1998)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment of a penetrating aortic ulcer (pau) using a conformable gore® tag® thoracic endoprosthesis with active control (ctag/ac).The pau was difficult to see under angiography, but it was identified as being approximately 4cm distal to the ostium of the left subclavian artery (lsa).The device was advanced and placed just distal to the lsa and deployed.The procedure was concluded.As the patient was being wheeled into recovery, he noted his left arm was getting numb.He was immediately brought back to the operating room where imaging showed that the graft material of the ctag/ ac was covering the lsa.Therefore, a gore® viabahn® vbx endoprosthesis was used as a chimney to restore perfusion to the lsa.The patient tolerated the procedure and was discharged to home on (b)(6) 2020.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: 10426850
• Report Number: 2017233-2020-01135
• Device Sequence Number: 16892001
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 06/03/2022
• Device Model Number: TGM343410
• Device Catalogue Number: TGM343410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91