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 TGMR404015

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

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 03/04/2024

Event Type  Death  

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #: tac083715a/ serial #: (b)(6) / udi #: (b)(4); catalog #: tsb081206a/ serial #: (b)(6) / udi #: (b)(4) which have been captured in manufacturer report #2017233-2024-04775.A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.D.10.Concomitant medical products and therapy dates: asked but unavailable.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.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.

Event Description

On (b)(6) 2024, the patient underwent endovascular treatment of an expanding penetrating aortic ulcer distal to the left subclavian artery.A gore® tag® thoracic branch endoprosthesis (tbe) aortic component (tac083715a), tbe side branch component (tsb081206a), and gore® tag® conformable thoracic stent graft with active control system (tgmr404015) were implanted.The procedure was reported as on label and performed per the devices' instructions for use.There were no reported issues during the procedure and the patient tolerated the procedure.Approximately two hours post-operatively, the patient reportedly coded.The patient was brought back to the operating room where the team performed compressions and resuscitative measures for approximately one hour.There was no reported rupture or other issue observed related to the device implant.The patient reportedly expired.The cause of the patient death remains unknown.

Manufacturer Narrative

G.4.Pma/510(k)number added.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d15 - there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.H.6.Investigation conclusions: code d12 added.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, death.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19014783
• MDR Text Key: 339065295
• Report Number: 2017233-2024-04776
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646845
• UDI-Public: 00733132646845
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/01/2024

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: TGMR404015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/01/2024
• Date Device Manufactured: 12/05/2023
• 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): Death
• Patient Age: 82 YR
• Patient Sex: Male