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	TGM343410
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The field sales associate (fsa) reported the following: it was reported that the physician had trouble with two gore® tag® conformable thoracic stent grafts during deployment while doing an elephant trunk procedure in zone 0 ascending aorta.The first device, gore® tag® conformable thoracic stent graft lot 25480131, was deployed without a wire and the physician ¿was unable to remove the red lockwire from the catheter.After accessing the deployment line access hatch and cutting the lockwire in channel 3.He was still unable to pull the wire and remove it from the catheter¿.At that time, the fsa suggested the physician to remove the entire device and try another gore® tag® conformable thoracic stent graft.The second gore® tag® conformable thoracic stent graft lot 26157550, during deploying it over an amplatz wire.There was no issue with the first two steps of deployment, when the physician went to release the red lockwire from the catheter, it once again would not release.He accessed the hatch and cut the wire in channel 3.However, could still not remove the wire.At this point, the fsa suggested cutting the catheter distal to the olive tip to release the graft.The physician did so, the graft released, and he retrieved the olive tip.The physician continued with the surgery and there were not any other adverse events with the case.
Additional Manufacturer Narrative
W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16727976
• Report Number: 2017233-2023-03860
• Device Sequence Number: 7293381
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2025
• Device Model Number: TGM343410
• Device Catalogue Number: TGM343410
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 03/18/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/02/2023
• Date Device Manufactured: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male