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
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Handling Problem (3265)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2017233-2022-02684
• Device Sequence Number: 5028388
• Product Code: MIH
• UDI-Device Identifier: 00733132646937
• UDI-Public: 00733132646937
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG