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

Catalog Number TGM343420J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

On (b)(6) 2021, a patient underwent endovascular treatment of a thoracic aortic disease using gore® tag® conformable thoracic stent graft with active control system (ctagac), tgm343420j.The patient had already undergone a total arch replacement and a frozen elephant trunk.The ctagac was implanted to extend distally from the elephant trunk.On unknown date (remains unknown), a pseudoaneurysm was observed at the distal end of the ctagac.On (b)(6) 2022, a reintervention was performed to treat the pseudoaneurysm.A gore® tag® conformable thoracic stent graft with active control system (ctagac), tgmr313120j, was implanted distally.A proximal type i endoleak of tgmr313120j was observed.To treat it, additionally gore® tag® conformable thoracic stent graft with active control system (ctagac), tgm343415j, was implanted proximally.A minor proximal type i endoleak was remained at an outer curvature.The physician decided to monitor it.The patient tolerated the procedure.The physician stated that regarding the pseudoaneurysm, the ctagac device might be oversized.Reportedly, tmg343420j might be used to treat a distal stent graft-induced new entry(sine) at the elephant trunk.But it was not confirmed.A vessel diameter at a location of the distal end of tgm343420j was originally 29 mm.Medical history: total arch replacement, frozen elephant trunk.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15255475
• MDR Text Key: 298193768
• Report Number: 2017233-2022-03239
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Catalogue Number: TGM343420J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male