MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGU313115
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: c19: a review of the manufacturing records indicated the lot met all the pre-release specifications.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
It was reported that on (b)(6) 2024, a patient was implanted with 31mm x 15cm gore® tag thoracic endoprosthesis (ctag device) to treat thoracic aortic aneurysm.The distance between the patient's aneurysm and left subclavian artery is 0.8mm.Therefore, the physician performed a bypass from the left common carotid artery to the left subclavian artery to extent landing zone.A lifetech stent was implanted prior to ctag device in the same procedure.The ctag device was advanced to distal left common carotid artery.After confirming the position was precise via imaging, the physician deployed ctag device.The deployment line was totally pulled out and the stent was successfully expanded.During withdrawing delivery system, a strong resistance was felt, and the delivery system couldn't be removed.The physician tried to exchange guidewires and pull with the snare, but the delivery system still couldn't be removed.Finally, the physician pulled delivery system with strong force, it was removed out.However, the sleeve which should have remained implanted between the stent and the vessel wall was removed out with delivery system.The stent was migrated to descending aorta.Another device was utilized to complete the procedure.The patient tolerated the procedure with no adverse experience.
Additional Manufacturer Narrative
H6: c19 - imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: one radiographic jpeg and 2 fluoroscopy movie clips are submitted for evaluation.Fluoroscopy movie #1 shows: the proximal marker of the delivery catheter is proximal to the proximal end of the implanted devices in the thoracic aortic arch/ascending thoracic aorta; pulling and releasing of the delivery catheter is visualized throughout movie #1; the proximal delivery catheter marker is still inside the proximal end of the devices at the end of this movie.Fluoroscopy movie #2 shows: this movie appears to show more forceful pulling of the delivery catheter; pulsing back and forth of the catheter is visualized also; unsuccessful attempts of removing the catheter on this movie.One radiographic jpeg image shows: the delivery catheter (marker) is pulled back from the proximal end of the devices.Engineering evaluation.The device evaluation showed the following: the deployment sleeve was connected to the trailing olive by the trailing leash line.The trailing leash line fiber appeared to be routed through a deployment sleeve stitch hole.The sleeve appeared fully deployed.Sleeve attachment holes were observed on the deployment sleeve.Sleeve attachment fibers were not present.No abnormalities were observed with the leading olive and leash line.The report of catheter withdrawal interference was confirmed during the evaluation of the returned device.Per the manufacturing product history review (phr), the device met all pre-release specification, and at the time of manufacturing there were no capas or ncrs related to this event.Due to the trailing leash line fiber routed through a sleeve stitch hole, as identified during the device evaluation, it is likely the failure mode is attributable to the manufacturing process.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19946900
• Report Number: 2017233-2024-05203
• Device Sequence Number: 7218898
• Product Code: MIH
• UDI-Device Identifier: 00733132617814
• UDI-Public: 00733132617814
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/13/2024

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 Catalogue Number: TGU313115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• 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: Male
• Patient Weight: 71 KG