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

Catalog Number TGU343415J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Infarction, Cerebral (1771)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

Complications associated with use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to stroke, paraplegia and paraparesis.

Event Description

On (b)(6) 2020, this patient underwent a total debranching thoracic endovascular aortic treatment for an aneurysm in the ascending aorta and the aortic arch using two conformable gore® tag® thoracic endoprosthesis.A tgu343415j was placed distally and a tgu454520j was placed proximally.The procedure was completed without reported issues.On (b)(6), 2020, it was reported that the patient had developed cerebral infarction during the time between after the procedure and (b)(6) 2020.It was reported that the cerebral infarction might have been caused by guidewire and/or delivery catheter manipulation in the aortic arch, or clamping of left common carotid artery.Reportedly, the exact cause of the cerebral infarction is unknown.In addition to cerebral infarction, multiple paralysis were also observed.Reportedly, no treatment for the cerebral infarction had been performed.The patient is being monitored.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10184694
• MDR Text Key: 196107268
• Report Number: 2017233-2020-01005
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2020

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: 11/11/2021
• Device Catalogue Number: TGU343415J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/23/2020
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 78 YR