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 TGMR313115E

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Rupture (2208)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that a patient with penetrating atherosclerotic ulcer underwent a thoracic endovascular aortic repair (tevar) treatment using a gore® tag® conformable thoracic stent graft with active control system.About one month after the implantation, the patient developed fever and the ct showed a proximal leakage into a periaortic hematoma.It was suspected that an infection may have weakened the aortic tissue which caused the rupture.The cause of the infection is unknown, hence it is not possible to confirm the relationship between the implanted device and the infection.The location of the rupture/leakage has not been confirmed.The patient allegedly is refusing intervention despite the suggestion from the clinic.

Manufacturer Narrative

H6: code f24 is used as the patient is refusing intervention.Imaging and serial numbers have been provided by the physician.A review of patient imaging and product history records is underway.The patient referenced in this event file is enrolled in the physicians initiated conforta clinical trial that is being done in spain and italy supported by leon research.This study is not a gore sponsored study.The conforta clinical trial has been designed to evaluate the safety, efficacy and cost analysis of the gore® tag® conformable thoracic stent graft with active control system for patients with descending thoracic aortic pathologies.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.

Manufacturer Narrative

The imaging evaluation performed by a clinical imaging specialist showed the following: one time-point is available for evaluation: post-implantation cta dated (b)(6) 2024.Metallic density in the lsa is consistent with embolization materials.Metallic density appears.To represent coiling in the lsa.The lsa is occluded from the embolization materials and proximally to the aorta.Multiple densities are seen within the aortic aneurysm sac.The grainy densities appear to be consistent with imh and/or infection.No contrast is visualized in the aortic aneurysm sac or outside the aorta walls.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to confirm the reported incident nor to determine the cause of this incident and assign a root cause.Per the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events, complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to: endoleak, hematoma, infection (e.G., aneurysm, device or access sites).

Manufacturer Narrative

H6: replaced e2013 with e230101.Added codes b20 (device remains implanted).As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.The device remains implanted and therefore no product evaluation has been performed.The imaging evaluation of newly provided images is ongoing.

Event Description

It was reported that a patient with penetrating atherosclerotic ulcer underwent a thoracic endovascular aortic repair (tevar) treatment using a gore® tag® conformable thoracic stent graft with active control system on (b)(6) 2023 at (b)(6) hospital.About one month after the implantation, the patient developed fever with blood cultures tested positive for streptococcus agalactiae.The patient underwent chest ct angiography on (b)(6) 2024, which showed regular patency of the aortic endoprosthesis, with the presence of a gross periprosthetic hypodense collection with a maximum diameter of 8 cm, with suspicious characteristics for prosthetic infection.The patient was transferred to (b)(6) on (b)(6) 2024 and was started on antibiotic therapy.The patient underwent urgent angiography and ct angiography, which showed an increase in the size of the periprosthetic collection associated with the appearance of blood supply from the collection itself, as shown by the double endoleak in the proximal sealing area of the aortic endoprosthesis.In view of the clinical and iconographic picture, an indication was given for surgical treatment by endovascular exclusion of the periprosthetically supplied haematoma at the level of the aortic arch.The patient is refusing intervention.The medical therapy was optimized to achieve adequate blood pressure control, and the patient was re-evaluated for infectious diseases with a view to returning home.The cause of the infection is unknown, hence it is not possible to confirm the relationship between the implanted device and the infection.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18585854
• MDR Text Key: 333771969
• Report Number: 2017233-2024-04565
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

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: TGMR313115E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 03/01/2024
• Supplement Dates FDA Received: 02/23/2024; 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2022
• 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): Other
• Patient Age: 83 YR
• Patient Sex: Male