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	Break (1069)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, this patient underwent emergent treatment of a descending thoracic aortic dissection and was implanted with gore® tag® conformable thoracic stent graft with active control system.Post deployment, fluoroscopy showed that the leading olive tip had become detached from the delivery system catheter and remained in the descending thoracic aorta.An additional device was implanted with the expanded device trapping the olive against the aortic wall.The reason for the detachment of the olive was unknown, the physician reported no difficulties with delivery, advancement, or anatomical issues for the patient.The patient tolerated the procedure.The device delivery catheter was retained by the site for analysis by gore.The results upon completion will be provided via submission of a supplemental medwatch.
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.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
The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the findings of the evaluation are consistent with the reported event description that the curved leading olive was separated from the catheter.Based on the device evaluation the olive was likely not sufficiently bonded to the catheter.The separation of the curved leading olive from the catheter is likely a manufacturing deficiency related to the cmds olive bonding process.Based on this investigation, the likely root cause is the catheter end was damaged post-trimming or pre-olive entry during the olive bonding process, resulting in insufficient braided shaft depth.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17154486
• Report Number: 2017233-2023-04037
• Device Sequence Number: 14896209
• Product Code: MIH
• UDI-Device Identifier: 00733132646951
• UDI-Public: 00733132646951
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 04/03/2026
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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: 53 YR
• Patient Sex: Male