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 TGM262620J

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577); Activation Failure (3270)

Patient Problem Vascular Dissection (3160)

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: code "device evaluation anticipated, but not yet begun" selected as the device has been returned but product evaluation has not been completed yet.(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2022, the patient underwent an endovascular treatment of a distal stent graft-induced new entry (d-sine) after frozen elephant trunk procedure.A gore® tag® conformable thoracic stent graft with active control system was delivered and it was done the first deployment from the distal of the previous implanted stent graft, however distal end of the gore® tag® conformable thoracic stent graft with active control system was not deployed.The access hatch was opened and the second deployment line was pulled, but there was strong resistance and it was not able to be pulled out.A wire was inserted form a 8fr sheath which was inserted from the opposite side.Then, the wire was cannulated into the undeployed distal end of the gore® tag® conformable thoracic stent graft with active control system and the pta balloon was used for expanding the distal end of the stent graft.The distal end of the stent graft was opened slightly, but the second deployment line was still not able to be pulled out.The line 3 and 4 were removed from the hatch.The 8fr sheath was changed to a gore® dryseal flex introducer sheath (18fr) and a gore® tri-lobe balloon catheter was delivered into the stent graft.Then, an overlap area, which was between the previous stent graft and the gore® tag® conformable thoracic stent graft with active control system, was hold by the gore® tri-lobe balloon catheter and the catheter of the gore® tag® conformable thoracic stent graft with active control system was removed.The second deployment line was observed from the outside of a valve of a 20fr gore® dryseal flex introducer sheath which was used for delivering gore® tag® conformable thoracic stent graft with active control system.Upon this second deployment line was pulled, the gore® tag® conformable thoracic stent graft with active control system was completely deployed.Additional gore® tag® conformable thoracic stent graft with active control system was implanted proximally as planned, then the procedure was completed.The patient tolerated the procedure.The physician stated the cause is unknown.

Manufacturer Narrative

Section h6 codes updated.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14467109
• MDR Text Key: 293365038
• Report Number: 2017233-2022-02952
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

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 Catalogue Number: TGM262620J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/22/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male