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

Catalog Number TGMR373710E

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 04/06/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, the patient underwent a stage endovascular procedure to treat zones 2 -4 thoracic aortic aneurysm.The patient had a zone 2 arch repair with the innominate and left common carotid arteries being debranched and an elephant trunk being placed proximal to the left common carotid but distal to the lsa.On (b)(6) 2024, a gore® tag® thoracic branch endoprosthesis (tac123415e/28051521) and a gore® tag® conformable thoracic stent graft with active control system (tgmr373710e/2707260) were placed into the upper descending aorta were implanted successfully.Sometime after operation, on (b)(6) 2024, there appears to have been a stroke.The physician believes it is right side hemispheric so is not related to the tbe implantation.Furthermore, that is may have happened prior to the implantation of the tbe.The physician is monitoring the patient.According to the physician, it was a technically successful procedure.Further information is not available.

Manufacturer Narrative

H6.Code c21: a review of manufacturing records is going to be conducted.The investigation is in process.The device remains implanted and is not available for analysis.Please note that the a gore® tag® thoracic branch endoprosthesis (tac123415e/28051521) was reported separately to fda and covered by the manufacturer report number 2017233-2024-04839.Also, the additional information was requested from the physician, however, the physician did not want to cooperate and provide any communication.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.According to the information provided, it was a stage procedure.According to the physician, it was a technically successful procedure.The physician believes that the stroke was at the right side hemispheric so is not related to the tbe implantation.Furthermore, that is may have happened prior to the implantation of the tbe.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to neurologic damage, local or systemic (e.G., stroke).Please note that the a gore® tag® thoracic branch endoprosthesis (tac123415e/(b)(6) was reported separately to fda and covered by the manufacturer report number 2017233-2024-04839.Also, the additional information was requested from the physician, however, the physician did not want to cooperate and provide any communication.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19131585
• MDR Text Key: 340448825
• Report Number: 2017233-2024-04840
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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 Catalogue Number: TGMR373710E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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): Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Male