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	TGMR373720
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Paralysis (1997); Paraplegia (2448)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device (s) caused or contributed to the event if any; additional device(s) implanted related to this event include: mpdcase-(b)(6): (b)(4) (lot/sn: (b)(4), udi: (b)(4) gore® tag® conformable thoracic stent graft with active control system - stent graft thoracic conformable active control.Mpdcase-(b)(6): (b)(4) (lot/sn: (b)(4) gore® tag® conformable thoracic stent graft with active control system - stent graft thoracic conformable active control.(b)(4).
Event or Problem Description
On (b)(6) 2022 the patient presented emergently with a ruptured thoracic aneurysm and was implanted with 3 gore® tag® conformable thoracic stent grafts with active control system.On (b)(6) 2022 the patient was observed to be experiencing paralysis in their legs.As reported, the patient was brought in, was emergently treated and the identified cause of the paralysis was due to the procedure as it involved extensive coverage of the aneurysm and there was no time to administer a spinal drain until the morning of (b)(6) 2022.Reportedly, the procedure involved coverage of the subclavian artery as well.The patient also reported numbness in the arms, but this symptom was present before the treatment of the rupture on (b)(6) 2022.The patient is currently being evaluated to determine the cause of the numbness and to determine if there are additional contributing conditions that may be present.As reported on (b)(6) 2022, the patient was doing ok, the patient was identified as weak but having regained function of their legs.The patient is going to rehab and will be coming back for open intrarenal repair.
Additional Manufacturer Narrative
B2: outcomes attributed to adverse event were previously left blank and have been specified.They include: required intervention to prevent permanent impairment/damage (devices); hospitalization - initial or prolonged; other serious (important medical events).
Additional Manufacturer Narrative
G3/g4: date received reflects the date this additional information was received for inclusion as part of the complaint investigation.B5: it was confirmed that the proximal implanted device was the tgmr373720 and the coverage of the subclavian was intentional.H6: code 2448, paraplegia was replaced with code 1997, paralysis.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14655224
• Report Number: 2017233-2022-03004
• Device Sequence Number: 4918933
• Product Code: MIH
• UDI-Device Identifier: 00733132646821
• UDI-Public: 00733132646821
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/20/2022

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: 10/31/2024
• Device Model Number: TGMR373720
• Device Catalogue Number: TGMR373720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 06/15/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 06/15/2022; 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/H11
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Male