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 TGM343415J

Device Problem Disconnection (1171)

Event Date 04/25/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2020, this patient underwent an emergency endovascular treatment for a thoracic descending aortic rupture due to chronic type b aortic dissection using gore® tag® conformable thoracic stent grafts with active control system (ctag acs; proximal tgm343415j, distal tgmr312610j).No endoleak was found.The patient tolerated the procedure.On (b)(6) 2023, a follow-up ct scan showed a type iiia endoleak from the connection site of the two ctag acs, and a reintervention was indicated.On (b)(6) 2023, an additional ctag ac was implanted at the connection site of the previous devices.The endoleak disappeared.The patient tolerated the reintervention.The reporting physician commented as follows: during the initial procedure, device overlap might have been insufficient.

Manufacturer Narrative

H.6.Investigation findings code b14: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation findings code b20: the device remains implanted and is not available for analysis.H.6.Investigation findings code d1102: the reporting physician commented as follows: during the initial procedure, device overlap might have been insufficient.Additional gore® tag® device captured on this report: sn: (b)(6).Udi: (b)(4).Catalog number: tgmr312610j.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.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17075204
• MDR Text Key: 316749559
• Report Number: 2017233-2023-03982
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Catalogue Number: TGM343415J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/06/2023
• Date Device Manufactured: 10/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male