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 TGM454520J

Device Problem Defective Device (2588)

Patient Problem Aneurysm (1708)

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The following was reported to gore: on (b)(6) 2022, this patient underwent open treatment for ascending and arch aortic aneurysm.A total arch replacement was performed, and a gore® tag® conformable thoracic stent graft with active control system (ctag ac device) was to be visually and anterogradely implanted instead of an open stent graft.During deployment of the ctag ac device, the stent graft was not deployed at all, whether the primary or secondary deployment line was pulled.There was reportedly more resistance than usual when pulling the primary and secondary deployment lines.Additionally, the red lockwire couldn¿t be pulled because of the strong resistance.The procedure was completed using a new stent graft (tgm454515j) without any reported issues.The patient tolerated the procedure.The device will be returned for further investigation.

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Product evaluation: failure to initiate primary deployment was found to be due to the broken primary deployment line in the handle.The morphology of the end of the primary deployment line suggests failure by tension.As part of the device evaluation, the primary deployment was successful when pulling the remainder of the primary deployment line.No abnormalities were identified with the sdl.The lockwire connector was damaged, but it is unknown whether this occurred during the procedure.The handle was disassembled by the physician prior to the engineering evaluation, which limited the information available during the device evaluation.During testing for design validation, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.There is potential that off-label use in an antegrade hybrid fashion may have contributed to the reported event.The root cause for the primary deployment line breakage, which led to failure to initiate primary deployment, could not be determined with the currently available information.No manufacturing deficiencies were identified during the device evaluation.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16023246
• MDR Text Key: 306796471
• Report Number: 2017233-2022-03593
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: TGM454520J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male