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 TGM343410E

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

It was reported to gore that the patient underwent an endovascular emergency procedure for acute type a dissection of the ascending aorta with a gore® tag® conformable thoracic stent graft with active control system.Reportedly the stent graft "failed to deploy correctly", the issue was not further specified.It was reported that the stent graft has been removed from the patient and an identical gore® tag® conformable thoracic stent graft with active control system has been used to completed the procedure.A longer intervention time was reported.

Manufacturer Narrative

A1: the patient id was not provided.The gore reference number was used instead.H6-b13: a requests was sent to the physician to clarify the deployment issue and anatomical boundary conditions.Furthermore patient details and status, as well as images of the case (pre-, intra-operative) and the device have been requested for evaluation.The answer is pending.H6-b14: the manufacturing records are being reviewed.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

D3: updated address for manufacturing site.

Manufacturer Narrative

Cause investigation and conclusion: additional information to the event, anatomical conditions, device information, and patient information were requested from the physician.Provided information were captured in sections 2 and 3.The device was requested to be returned for evaluation.A review of the manufacturing records indicated the lot met all pre-release specifications.The device was returned incomplete for investigation.The evaluation summary states the following: the lockwire connector was protruding slightly from the white handle component.The connector was broken from the rest of the lockwire handle, which was not returned.The lockwire was correctly routed through the rest of the device.The lockwire was pulled back slightly outside of the olive.Both angulation fibers were properly routed through the stent graft.Both angulation fibers had intact loops and were attached to the lockwire.One angulation fiber was routed into the transition.Angulation fibers were not present in the deployment hatch and could not be seen in the white handle component.As part of the device evaluation, the lockwire was able to be removed from the device with the catheter assembly held in a straight position and tracked over a guidewire.No manufacturing deficiencies were identified during the device evaluation and device history review.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.The gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail.The ifu states the following: backup deployment mechanism: in the event that removing the red lockwire handle does not initiate removal of the lockwire from the catheter, and the problem is suspected to have occurred in the deployment hub, the deployment hub has a feature designed to protect the patient against this problem becoming a hazard.Remove the deployment line access hatch (see figure 9 and associated caution in step 12) then cut and pull the lockwire in the channel labeled 3 with an appropriate tool.Fully remove the lockwire with a steady motion.This action will remove the lockwire from the catheter.

Event Description

It was reported to gore that the patient underwent an endovascular emergency procedure for acute type a dissection of the ascending aorta with a gore® tag® conformable thoracic stent graft with active control system.Reportedly the device could not be deployed because the lockwire could not be removed.It was reported that the device was removed from the patient and an identical gore® tag® conformable thoracic stent graft with active control system has been used to complete the procedure.A longer intervention time was reported.The patient tolerated the procedure.

• 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.; 3750 w. kiltie lane; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17258759
• MDR Text Key: 318857773
• Report Number: 3007284313-2023-02593
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2023

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: TGM343410E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 06/13/2023; 06/13/2023; 06/13/2023
• Supplement Dates FDA Received: 10/17/2023; 10/27/2023; 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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 Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male