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	TGMR373715
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event/date of birth: asked but unavailable.Gender: asked but unavailable.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 4112 - the device remains implanted, and the delivery catheter was discarded at the facility.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.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
On (b)(6), the patient underwent open treatment of a ruptured thoracic aortic dissection using a gore® tag® conformable thoracic stent graft with active control system.It was reported that, as the physician rotated the red lockwire handle to initiate removal of the lockwire, the lockwire broke away from the handle.There was no resistance reported prior to the lockwire break.There was no reported suspected cause for the lockwire break.It was noted that the device was deployed over a guidewire.It was reported that the physician opened the handle (not the backup deployment hatch) and manually grabbed the lockwire to complete deployment.Deployment was successfully completed.There were no further reported issues.There were no patient adverse events.The patient tolerated the procedure.
Additional Manufacturer Narrative
After review by post market surveillance quality, the following was determined: according to the reportability guidelines for this device, deployment line breakage occurring when the device is inside the patient is deemed a reportable malfunction event.However, if deployment was able to be completed using the device¿s back-up deployment mechanism, the event of deployment line breakage is deemed non-reportable.In this incident, the physician was able to pull the lockwire out of the end of the catheter handle, thus releasing the device from the delivery catheter.The lockwire could have been successfully removed in this situation by using the backup deployment hatch if the physician had chosen to use it.Additionally, no patient harms occurred and the device was successfully deployed.Therefore, this incident does not meet the definition of a reportable malfunction.This medwatch will be retracted.

• 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: 15188663
• Report Number: 2017233-2022-03196
• Device Sequence Number: 5542361
• Product Code: MIH
• UDI-Device Identifier: 00733132646814
• UDI-Public: 00733132646814
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2024
• Device Model Number: TGMR373715
• Device Catalogue Number: TGMR373715
• 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: 07/09/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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 Sex: Unknown