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 TGM282810

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

The gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) states: patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.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 information was reported to gore: on (b)(6) 2023, a gore® tag® conformable thoracic stent graft with active control system was explanted.Patient was being treated for blunt thoracic injury.It was reported that while the physician was deploying the gore® tag® conformable thoracic stent graft with active control system, the first two handles were pulled and device engaged, however while the lockwire was still engaged, the physician started pulling the delivery catheter down and out of patient.This caused the device to move down and "crumple on itself", below the celiac artery and superior mesenteric artery.The deployment could not be resolved during endovascular procedure.The physician chose to perform an open repair and explant the graft.The patient tolerated the procedure.

Manufacturer Narrative

H6: investigation conclusions code d1101: the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) also states: once the device is in its desired position, release the device from the delivery catheter by rotating the red lockwire handle 90° counter-clockwise and pulling in a steady motion.The gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) also states: warning: the device remains attached to the catheter via the lockwire immediately following deployment to full diameter.Do not move the catheter or handle as unintended device movement or vessel damage may occur.Updated code d15 to d1101.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19035916
• MDR Text Key: 339320905
• Report Number: 2017233-2024-04787
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646937
• UDI-Public: 00733132646937
• 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
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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: TGM282810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 82 KG