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 TGM454520

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #tgm454520/ serial #(b)(4)/ udi #(b)(4) which is captured in manufacturer report #2017233-2021-01588.

Event Description

On (b)(6) 2020 the patient underwent phase ii of thoracic aortic treatment using gore® tag® conformable thoracic stent grafts with active control system (ctag a/c).It was reported that one week prior the patient had undergone open repair and total arch replacement using a frozen elephant trunk technique.Phase ii was performed to treat a thoracic aortic aneurysm and dissection.A 300cm glidewire guidewire was used with a through and through technique from the patient's right brachial artery to the right common femoral artery.It was reported that a 24fr.Gore® dryseal flex sheath was advanced on the patient's right side through the common femoral artery.Reportedly an attempt was made to place a ctag a/c in the previously implanted frozen elephant trunk device.It was reported that the patient had two 180 degree bends in the aorta (described as an "s" curve).It was reported that the physician was pulling tension on the through wire.As the ctag a/c was exiting the introducer sheath it was reported that the first aortic bend was successfully navigated, but as the device was advanced further the leading olive tip and device began to separate at the junction.Reportedly the leading olive tip began to point towards the patient's head and the device went in the opposite direction.The leading olive tip did not separate from the delivery catheter and the intact device was removed from the patient.Upon inspection it was reported that the ptfe wrapping around the constrained device had separated slightly and the partially uncovered stent row of the device was exposed.It was reported that the introducer sheath was advanced further and a second ctag a/c device was advanced.The device was unable to navigate the s-curve and the same stretching and movement between the leading olive tip and constrained device occurred.The intact device was successfully removed from the patient with the same separation of the leading ptfe wrapping noted.It was reported that a 42mmx38mm cook medical zenith alpha graft was successfully advanced through the anatomy and deployed.Two additional cook medical zenith alpha grafts and one additional ctag a/c device were used to complete the procedure.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #tgm454520, serial # (b)(6), udi # (b)(4) which is captured in manufacturer report #2017233-2021-01588.H.6.Investigation findings: code 213 - the devices were returned to gore for evaluation.The engineering evaluation found the following: per the manufacturing product history record review the devices met all pre-release specifications.The devices, both tgm454520s, were returned for evaluation.Based on the evaluation, the partially uncovered stent row of the devices could be confirmed.On both devices, stent apices on the proximal end were exposed.The sleeve bunching indicates that the sleeve shifted distally.However, the reported cause could not be confirmed.There is no indication of relation to a manufacturing deficiency.As mentioned in the event description, the patient's anatomy was abnormal (horizonal s-curve) which may have contributed to the observations of the olive and stent overhang.Based on the reported event description, product history review, imaging evaluation, and review of the risk documentation, no design failure modes, process failure modes, or use errors could be confirmed to be directly related to the reported event description.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, failure to deliver the stent graft, and insertion or removal difficulty.Furthermore, the ifu states that the safety and effectiveness of the gore® tag® conformable thoracic stent graft have not been evaluated in patient etiologies including, but not limited to, previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 4310.

• 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
• MDR Report Key: 11147725
• MDR Text Key: 226069886
• Report Number: 2017233-2021-01589
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132647002
• UDI-Public: 00733132647002
• 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: 03/30/2021

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: 04/09/2023
• Device Model Number: TGM454520
• Device Catalogue Number: TGM454520
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYPERTENSIVE MEDICATION, ASPIRIN, AMPER.; HYPERTENSIVE MEDICATION, ASPIRIN, AMPER.
• Patient Age: 37 YR
• Patient Weight: 272