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 TGMR313120J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pseudoaneurysm (2605)

Event Date 09/13/2022

Event Type  Death  

Manufacturer Narrative

Code "other" was selected as the medical device remains implanted.Return not possible.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, but in (b)(6) 2022, a pseudoaneurysm was observed at the distal end of the ctagac.On (b)(6) 2022 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 remained at an outer curvature.The physician decided to monitor it.The patient tolerated the procedure.((b)(4)) on (b)(6) 2022, new pseudoaneurysm was observed at the distal end of the ctagac #tgm313120j.On (b)(6) 2022, the pseudoaneurysm ruptured.Unable to treat, the patient passed away.The physician stated that he thought that the device, tgm313120j, was the right size, but the cause was unknown.Reportedly, a semi-emergency thoracic endovascular aortic repair was scheduled for (b)(6) 2022.

Manufacturer Narrative

Emdr section h6 codes were updated to reflect the result(s) of the investigation.

• 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: 15597982
• MDR Text Key: 301713254
• Report Number: 2017233-2022-03403
• 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,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TGMR313120J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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): Death
• Patient Age: 76 YR
• Patient Sex: Male