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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
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: endoleak, reoperation, endoprosthesis: migration cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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
On (b)(6) 2023, this patient underwent endovascular treatment of a zone 2 dissection and was implanted with gore® tag® thoracic branch aortic components (tbe).The patient tolerated the procedure with good results and good seal.On (b)(6) 2023, the physician reported the patient has a proximal type i edoleak associated with the tsb081506a/26311136.The physician plans to reintervene on wednesday, (b)(6) 2023.The physician believes they may have not achieved enough purchase up into the left subclavian artery with the gore® tag® thoracic branch endoprosthesis side branch component (tsb).When initially deployed due the dissection, the portal had not been landed exactly at the lsa; so when deployed it there were some distance from the portal to get to the left subclavian.Final run had shown good seal initially however the physician believes the tsb has slipped out of the portal portion of the branch device and there a type i endoleak and contrast can be seen leaking from the top of the left subclavian branch into back into the dissection.On (b)(6) 2023, the patient underwent reintevention and the endoleak was treated by extending the lsa branch device, using a gore® viabahn® vbx balloon expandable endoprosthesis.The patient tolerated the procedure and the endoleak was resolved.

• 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: 17898846
• Report Number: 2017233-2023-04322
• Device Sequence Number: 3429997
• Product Code: MIH
• UDI-Device Identifier: 00733132654383
• UDI-Public: 00733132654383
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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
• Report Date (Section B): 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2026
• Device Catalogue Number: TSB081506A
• 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: 10/02/2023
• Initial Report FDA Received Date: 10/09/2023
• Date Device Manufactured: 01/31/2023
• 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: 68 YR
• Patient Sex: Male