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

Catalog Number	TGMR404020
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, a patient was to be implanted with a 40mm x 20cm gore® tag® conformable thoracic stent graft with active control system (cmds device) to treat aneurysm at aortic arch.Cmds device was planned to be placed at ascending aorta, and "chimney" technique was used to reserve some branches of the arch.After inserting the dsf2233 sheath and delivering cmds device to target lesion, physician pulled the first deployment handle.Under dsa fluoroscopy, cmds device was not expanded.Physician continued to pull the second deployment handle, cmds device was still not expanded.No abnormal resistance was felt when pulling the deploy handle.Physician carefully retracted cmds device into sheath and removed out of body.Another cmds device was used and was successfully deployed.The remaining procedure was completed according to the preoperative plan.The procedure was smooth, and the patient's condition was stable and was returned to the ward safely.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.D6: the device was not implanted nor explanted.H6 - investigation findings: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Returned device is under evaluation by w.L.Gore & associates, inc.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.
Additional Manufacturer Narrative
H6: code d15 -engineering evaluation: the device evaluation showed the following: the fully constrained gore® tag® conformable thoracic stent graft with active control system (cmds) device was returned for evaluation.The primary deployment line (pdl) was identified to be broken near the proximal end of the device, attached to the stent graft and sleeve.The primary deployment line that remained connected to the primary deployment knob measured approximately 103.5cm.The observations of the device evaluation support the physician¿s report of the device not expanding to intermediate diameter following primary deployment.Based on the length of the returned secondary deployment line (sdl) that remained connected to the secondary deployment knob, there was no indication of an issue with the sdl.The device likely did not expand when the sdl was removed due to the device remaining constrained by the primary sleeve.The observations of the device evaluation support the physician¿s report of the device not expanding following secondary deployment.The core and outer wrap of the pdl fiber appear to have experienced tensile forces and are not indicative of a clean cut.Primary deployment not completing is likely due to the primary deployment line breaking.The deployment line appears to have broken due to tensile forces.The cause of the primary deployment line breaking could not be confirmed with the currently available information.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17547416
• Report Number: 2017233-2023-04202
• Device Sequence Number: 6684236
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 01/10/2026
• Device Catalogue Number: TGMR404020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 38 KG