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	TGMR312610
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.Type of investigation: code (b)(4): images were provided, and an imaging evaluation will be performed.
Event or Problem Description
On (b)(6) 2022 the patient underwent emergent repair of a blunt traumatic aortic injury using a gore® tag® conformable thoracic stent graft with active control system (ctag a/c).It was reported that the physician intentionally covered the patient's left subclavian artery.The device was successfully advanced up to the patient's left common carotid artery.It was reported that there were no issues with device placement upon close of the procedure.It was also noted that the device was not ballooned after deployment due to the traumatic nature of the injury.On (b)(6) 2022 the gore representative was informed that the patient had experienced a stroke.It was reported that follow-up imaging revealed that the ctag a/c device had migrated proximally.The device was reportedly covering most or all of the patient's left common carotid artery and the stroke was attributed to the artery coverage.The patient reportedly survived the stroke.It was reported that some stroke intervention was performed but details are unavailable.Other outcomes are reportedly unknown.
Additional Manufacturer Narrative
H.6.Type of investigation codes b14 and b15 remain unchanged.H.6.Investigation findings code c19 for type of investigation b14 remains unchanged.H.6.Investigation findings code c19 for type of investigation b15: an imaging evaluation was performed by a clinical imaging specialist and the evaluation found the following: two time-points were available for evaluation- post-implantation head/neck cta dated (b)(6) 2022 and post-implantation chest cta dated (b)(6) 2022.Post-implantation head/neck cta dated (b)(6) 2022 appeared to show that the proximal end of the implanted device was located at the distal border of the brachiocephalic artery.Ap 3d and axial imaging appeared to show no flow in the left common carotid artery (lcca).There appeared to be flow in the left subclavian artery (lsa).Post-implantation chest cta dated (b)(6) 2022 appeared to show no flow visualized in the lcca.The lsa appeared to be patent.Unable to visualize any movement of the proximal end of the implanted device since the (b)(6) 2022 time-point.Migration of the device could not be confirmed with the imaging provided for evaluation.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, stent graft migration, branch vessel occlusion or obstruction, and transient ischemic attack or neurologic damage, local or systemic (e.G., stroke).Furthermore, the ifu instructs users that, when treating emergent patients (e.G., ruptured aneurysms, traumatic transections, acute complicated type b dissections) where revascularization may not be possible prior to stent graft placement due to the patient¿s condition, it is important to weigh the potential increased risk of stroke with the benefits of treatment.Patients presenting with ruptured aneurysm, traumatic transection, and acute dissection may be at higher risk for complications associated with general anesthesia.H.6.Investigation findings code for type of investigation b15 has been updated from 3233 to c19 - no device problem found.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15009334
• Report Number: 2017233-2022-03120
• Device Sequence Number: 2414035
• Product Code: MIH
• UDI-Device Identifier: 00733132646760
• UDI-Public: 00733132646760
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2024
• Device Model Number: TGMR312610
• Device Catalogue Number: TGMR312610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male