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 TGMR373710J

Device Problem Disconnection (1171)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

H6: b20, the device remains implanted and was therefore not available for engineering evaluation.H6: c19, a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.It should be noted the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) state ¿complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to endoleak.Please note that the same patient was captured in medwatch 2017233-2023-03866.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) 2023, the patient underwent an endovascular treatment of a thoracic aortic aneurysm using gore® tag® conformable thoracic stent grafts with active control system.A non-gore stent graft (relaypro) was implanted proximally.And then, the gore® tag® conformable thoracic stent graft with active control system (tgmr37315j) was implanted just above the superior mesenteric artery.On (b)(6) 2023, second reintervention was performed to treat a proximal type i endoleak of the non-gore stent graft (relaypro) which was implanted on (b)(6) 2023.A gore® tag® conformable thoracic stent grafts with active control system was implanted proximal of non-gore stent graft (relaypro) and the type ia endoleak was resolved.During this reintervention, a 4dct revealed that a type iiia endoleak.The type iiia endoleak might have been from between gore® tag® conformable thoracic stent graft with active control system (tgmr37310j) which was implanted on (b)(6) 2023 and the non-gore stent graft which was implanted distally of tgmr37310j on(b)(6) 2023.A gore® tag® conformable thoracic stent grafts with active control system was implanted to reline.The patient tolerated the procedure.

Manufacturer Narrative

H6: added f1901 additional surgery under health effect - impact code.H10: corrected ifu to: it should be noted the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) state ¿complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to endoleak and reoperation.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16865522
• MDR Text Key: 314528206
• Report Number: 2017233-2023-03906
• 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,Followup
• Report Date: 06/13/2023

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 Catalogue Number: TGMR373710J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/13/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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): Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male