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

Catalog Number TGMR373720E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Additional medical device involved in this event: gore® tag® conformable thoracic stent grafts with active control system tgm454515e/20757723.Udi for this device: (b)(4).(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2019, this patient underwent endovascular treatment for a thoracic aortic aneurysm and was treated with two gore® tag® conformable thoracic stent grafts with active control system.Prior to the implant, a carotid-subclavian bypass involving both carotid arteries was performed to create a landing zone for the endoprostheses.On procedure day in the evening, the patient was reported to have suffered middle cerebral artery ischemia, necessitating re-intubation on the intensive care unit.According to the physician, the stroke was secondary to the surgery and considered unrelated to the implant.

Manufacturer Narrative

H6, code 22: according to the gore® tag® conformable thoracic stent graft instructions for use (ifu), adverse events which may require intervention and/or conversion to open repair include, but are not limited to: cerebrovascular accident.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9407851
• MDR Text Key: 182965261
• Report Number: 2017233-2019-01208
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Catalogue Number: TGMR373720E
• Device Lot Number: 20697755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 90