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 TGMR373715

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2023

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu), complications associated with the use of the gore® tag® conformable thoracic stent graft with active control system may include but are not limited to: stent graft: incomplete deployment.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

On (b)(6) 2023, this patient underwent open surgical/endovascular treatment.The physician reported that a gore® tag® conformable thoracic stent graft with active control system was introduced and advanced within a frozen elephant trunk (fet) on a terumo glide wire from the aortic arch antegrade into the aorta into and descending aorta.Stage one and two of deployment were completed but stage 2 (deployment to full diameter) could not be completed as the red slider on the angulation fiber handle would not retract fully from the device.It was reported that they physician pulled and pulled on it with enough force that finally they broke the red plastic slider.Deployment was then successfully completed using the back up deployment mechanism.The patient tolerated the procedure.

Manufacturer Narrative

The device delivery catheter was returned to gore and an engineering evaluation was performed and provided the following: the lockwire was not returned with the device, therefore the alleged inability to remove lockwire could not be confirmed.The stent graft was not returned, and the fibers associated with the other deployment lines were not returned routed through the device.Therefore, partial deployment could not be confirmed.Since the stent graft was not returned, it appears that deployment was completed using the backup deployment mechanism could be confirmed.The lockwire handle was evaluated, and the lockwire connector was broken.The broken connector is likely the cause of the alleged inability to remove the lockwire.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.Based on the event description and device evaluation no manufacturing deficiencies were identified so no capa request is required.Events will continue to be monitored by gore.

Manufacturer Narrative

Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 2017233-2023-04189 was submitted in error and is hereby retracted.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17574904
• MDR Text Key: 321534523
• Report Number: 2017233-2023-04189
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646814
• UDI-Public: 00733132646814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TGMR373715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 07/29/2023; 07/29/2023
• Supplement Dates FDA Received: 08/24/2023; 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG