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

Model Number TGM282810

Device Problems Difficult to Fold, Unfold or Collapse (1254); Device Handling Problem (3265)

Patient Problem Ulcer (2274)

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Patient medical history includes but is not limited to: lung disease, osteopenia, glaucoma.Patient medications include but are not limited to: albuterol, budesonide, carvediol according to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to include: stent graft: incomplete deployment.

Event Description

On (b)(6) 2022, this patient underwent endovascular treatment of a penetrating aortic ulcer and a gore® tag® conformable thoracic stent graft with active control system (ctag ac) was implanted.It was reported that the physician loosened and turned the gray secondary deployment handle and pulled back to deploy the device to it¿s full diameter but the deployment line got stuck after having only been pulled out about an inch.The physician then pulled back harder and the deployment line broke.The lockwire and angulation assemblies were removed with the device delivery system.A balloon catheter was then advanced to balloon the device to full expansion.The procedure was concluded with full expansion of the device and successful placement where intended.The patient tolerated the procedure.

Manufacturer Narrative

The device delivery catheter and deployment system were returned to gore for evaluation and showed the following: the secondary deployment line (sdl) that remained connected to the secondary deployment knob measured approximately 114.5cm.This is significantly shorter than the approximate 144.4cm sdl attached to the deployment knob of a fully deployed secondary sleeve on a separate device.The core and outerwrap of the fiber appear to have experienced tensile forces and are not indicative of a clean cut.The length of the returned sdl is indicative of the line breaking, supporting the physician¿s observation of the device was not fully deployed following secondary deployment.Secondary deployment not occurring is likely due to the secondary deployment line breaking.The deployment line appears to have broken due to tensile forces.The cause of the secondary deployment line breaking could not be confirmed with the available information.No process failure mode could be confirmed, and no manufacturing deficiencies were identified during the device evaluation.No capa request is required and events will continue to be monitored by gore.

• 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: 13318141
• MDR Text Key: 290550181
• Report Number: 2017233-2022-02684
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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 Expiration Date: 03/31/2022
• Device Model Number: TGM282810
• Device Catalogue Number: TGM282810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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 Sex: Male
• Patient Weight: 75 KG