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

Catalog Number	TSB081506A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
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.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
Fsa reported "side branch was being pushed through portal of thoracic side branch device.Physician had difficulty in advancing through portal and continuously twisted delivery catheter.Device was eventually deployed in appropriate location of lsa.Upon deployment and after delivery catheter was removed, it was noted that the nose cone and inner canula was left behind on the wire.Attempt was made at snaring.Ultimately the nose cone and canula were removed via axillary cutdown.".
Additional Manufacturer Narrative
H6: code d12 ¿ the gore tag thoracic branch endoprosthesis includes the following caution: do not rotate the side branch component delivery catheter.Catheter breakage or inadvertent deployment has occurred.
Additional Manufacturer Narrative
H.6.Investigation findings: code c21 updated to code c23 with completion of device evaluation.H.6.Investigation conclusions: code d16 updated to code d11 with completion of device evaluation.The device was returned for evaluation.The evaluation stated: 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), mpdcase-00017145-1, a review of the manufacturing records indicated that the manufacturing lot met all pre-release specifications.The root cause for the leading end of the catheter breaking was likely associated with torquing of the catheter after having difficulty in advancing it through the portal.A manufacturing deficiency associated with the tbe side branch was not identified during the device evaluation.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18595993
• Report Number: 2017233-2024-04569
• Device Sequence Number: 20547531
• Product Code: MIH
• UDI-Device Identifier: 00733132654383
• UDI-Public: 00733132654383
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2024

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 Expiration Date: 04/17/2026
• Device Catalogue Number: TSB081506A
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 01/04/2024; 01/04/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/19/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female