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

Catalog Number	TSB121506A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use (ifu) states, possible adverse events and complications that may occur with the use of gore® tag® thoracic branch endoprosthesis include, but are not limited to: access, delivery and deployment events (e.G.Access failure; deployment difficulties/failures), endoprosthesis: incomplete deployment.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 the encode emergence is more difficult to seat properly.Doctor feels there is a changed hex tolerance between the original encode and encode emergence.The emergence tolerance seems to be tighter and more difficult to seat.The doctor estimated the group has had more than 30 cases where seating is an issue since launch.Contacted customer and sales rep for additional information but neither had any specifics regarding previous occurrences besides that they were able to complete the procedures either by backing the screw slightly to get the abutment to seat properly or replacing it with the original encode.
Additional Manufacturer Narrative
The gore® tag® thoracic branch endoprosthesis (tbe) device evaluation showed the following: the tbe side branch (sb) catheter separated at the distal shaft.The findings of the evaluation are consistent with the reported event of leading end of the catheter broken.Per the manufacturing product history review (phr), (b)(4), a review of the manufacturing records indicated that the manufacturing lot met all pre-release specifications.A root cause cannot be confirmed for the reported events of partial deployment, leading end of catheter broken, and deployment line broken.However, the incomplete deployment of the side branch was likely caused by deployment line breakage due to interaction with a previously implanted tavr device.The side branch catheter breakage was likely a result of torquing the catheter in an effort to complete the deployment of the device.A manufacturing deficiency associated with the tbe side branch was not identified during the device evaluation.Therefore, no capa request is required.Events will continue to be monitored by gore.The instructions for use (ifu) for the gore® tag® conformable thoracic stent graft cautions: do not rotate the sb component delivery catheter.Catheter breakage or inadvertent deployment has occurred.

• Brand Name: GORE® TAG® THORACIC BRANCH 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17499258
• Report Number: 2017233-2023-04193
• Device Sequence Number: 2442806
• Product Code: MIH
• UDI-Device Identifier: 00733132654406
• UDI-Public: 00733132654406
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 03/07/2024
• Device Catalogue Number: TSB121506A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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 Age: 82 YR
• Patient Sex: Male