MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGMR373720J

Device Problems Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem Aortic Dissection (2491)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

According to the instructions for use (ifu) for the conformable gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to include: stent graft migration or realignment, deployment failure a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for an aortic arch dissection and was implanted with conformable gore® tag® thoracic endoprostheses and gore® tag® conformable thoracic stent graft with active control system.Pre-implant, a right carotid artery to left carotid artery bypass was performed.A conformable gore® tag® thoracic endoprosthesis (ctag) was then implanted proximally within the ascending aorta, followed by a gore® tag® conformable thoracic stent graft with active control system (ctagac) which was landed 5 mm distal to the brachiocephalic artery and extended distally to the aortic curve and overlapped inside a previously implanted valiant® thoracic stent graft.The primary deployment of the ctagaz to the intermediate diameter was completed without issue, and the deployment handle was pulled to initiate the secondary stage of deployment; but the deployment line was reported to have become stuck and could only be pulled about halfway resulting in the proximal end failing to fully deploy.The deployment line was pulled with force but was unable to be pulled out.According to the physician, the deployment line was believed to have been stuck at the inner aortic curvature due to the acute angle of the patient's aortic curve where the ascending/descending aorta meet; and also the area of overlap zone of the ctagac and the valiant graft.At this time the physician pulled the lock wire handle first and removed the delivery catheter and the deployment line was successfully removed from the patient; but the proximal end still remained only partially deployed.A gore® tri-lobe balloon catheter was used to deploy the proximal end of the ctagac however during touch-up, the ctagac migrated/moved distally approximately 4 cm.As a result of the migration, infolding of the device was visualized and an additional ctag was implanted within this area, however it did not resolve the infolding.Resolved.The procedure was concluded.The patient tolerated the procedure.

Manufacturer Narrative

H6: added additional conclusion code.H6: code 4117: no device evaluation could be performed as the device was not returned.Therefore the event description of the secondary deployment line (sdl) locking up could not be evaluated.Per the manufacturing evaluation the device met all pre-release specifications and there are no capas or ncrs related to this event.Per the imaging evaluation a relationship to this event could not be evaluated based on the available images.A root cause for the secondary deployment line (sdl) locking up cannot be determined with the currently available information.Due to the deployment line locking up during deployment, there is potential for the failure mode to be attributable to the manufacturing process.The worst-case severity of harm that is reasonably foreseeable for this scenario is serious.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9528121
• MDR Text Key: 195591482
• Report Number: 2017233-2019-01280
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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: 06/09/2022
• Device Catalogue Number: TGMR373720J
• Device Lot Number: 20863281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR