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	TGM454515
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, the patient underwent a pre-planned open procedure with a frozen elephant trunk (fet) procedure utilizing a gore® tag® conformable thoracic stent graft with active control system (tgm454515) off the shelf.Reportedly, upon the deployment of the device, the secondary deployment line where the red handle/line comes off the thumb level was either stuck or broken, when the physician twisted it.The deployment line broke and the physician was unable to use the graft.The physician was able to complete the case with a separate like device and had no issues deploying.A gore representative was not present for this case.
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 2017233-2023-03688 was submitted in error and is hereby retracted."review of the file determined this event to be non-reportable, as no patient adverse events, or other serious injury has been reported and this was a planned open procedure".Therefore, this medwatch will be voided.".

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16308773
• Report Number: 2017233-2023-03688
• Device Sequence Number: 12463280
• Product Code: MIH
• UDI-Device Identifier: 00733132646999
• UDI-Public: 00733132646999
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Model Number: TGM454515
• Device Catalogue Number: TGM454515
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown