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	TGMR404020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse outcomes noted.Patient tolerated the procedure.Additional information on patient medications and comorbidities was requested but was not provided.(b)(4).
Event or Problem Description
On (b)(6) 2022, the patient underwent treatment for a thoracic aortic aneurysm (taa).As reported, during the procedure the gore® tag® conformable thoracic stent graft with active control system did not angulate in the appropriate plane (1960-e:-other/unknown).The horizontal bar in olive tip appeared to be separated and superior to the central wire lumen (lunderquist.) angulation and stent nesting occurred in either the 9:00 or 3:00 position instead of the inner curve as desired.The issue was not observed to be related to any anatomical factors.The patient¿s arch was steep and there was slight anterior ¿ posterior positioning of the ascending to transverse arch.The patient was treated successfully and tolerated the procedure.
Additional Manufacturer Narrative
Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 2017233-2022-02833 was submitted in error, and is hereby retracted.Per md24757 as there was no catheter breakage, shaft detachment, or olive separation occurring during the procedure and there were no unplanned surgical procedures this is not a reportable event.B4 was updated with the current description summary following clarification from the field.
Event or Problem Description
On (b)(6) 2022, the patient underwent treatment for a thoracic aortic aneurysm (taa).As reported, during the procedure the gore® tag® conformable thoracic stent graft with active control system did not angulate in the appropriate plane.Angulation and stent nesting occurred in either the 9:00 or 3:00 position instead of the inner curve of the patient anatomy as desired.When viewing with angiography, the horizontal marker bar in olive tip had proper separation and appeared to be separated and superior to the central wire lumen (lunderquist), indicating that the graft was orienting correctly with the anatomy.Computed tomography angiography (cta) and centerline images were provided for consideration as part of the investigation.Provided imaging indicated that that the olive tip appeared to be steering the device correctly around the arch.The issue was not observed to be related to any anatomical factors.The patient¿s arch was steep and there was slight anterior ¿ posterior positioning of the ascending to transverse arch.The patient was treated successfully and tolerated the procedure.

• 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: 13938649
• Report Number: 2017233-2022-02833
• Device Sequence Number: 6431585
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/06/2022

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 Expiration Date: 11/27/2024
• Device Model Number: TGMR404020
• Device Catalogue Number: TGMR404020
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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
• Patient Age: 59 YR
• Patient Sex: Male