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 TGMR312610J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Vascular Dissection (3160)

Event Date 03/21/2024

Event Type  Injury  

Event Description

On (b)(6) 2023, this patient underwent an endovascular treatment of a chronic type b aortic dissection with onset in 2014 using gore® tag® conformable thoracic stent graft with active control system(ctag/ac device).It was reported that two ctag/ac devices were implanted.Reportedly, a maximum short diameter was 48 mm on a follow-up computed tomography(ct) imaging at 1 month postoperatively.On (b)(6) 2024, the patient had a chest pain.A false lumen enlargement of more than 5 mm (maximum short diameter was 55 mm) was observed on a ct imaging, and also an aortoesophogeal fistula was suspected.A reintervention was planned on (b)(6) 2024.On (b)(6) 2024, the patient had a hemoptysis.A new dissection at the distal side(distal stent graft-induced new entry/dsine) and further false lumen enlargement (maximum short diameter was 59 mm) were observed on a ct imaging.And also a fistula was observed between the false lumen and esophagus.It was determined that it was bleeding into the esophagus via a false lumen from a new dissection, and emergency reintervention was performed and an additional stent graft was placed on the distal side.The patient tolerated the procedure.The physician reported that no endoleak was observed on the ct imaging on (b)(6).Due to the esophageal fistula, oral antihypertensive medication could not be administered, and the patient's blood pressure remained high, approximately 170, which might have caused dsine.The cause of the esophageal fistula is unknown.

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ two pre-implantation drawings and two post-implantation radiographic jpeg images submitted for evaluation.¿ no name, date, or demographics on the images.¿ cannot provide any diameters or lengths with images provided.¿ all annotations with the images provided were completed before being submitted to gore.¿ pre-implantation drawings are suggestive of a dissected thoracic and abdominal aorta, however, cannot confirm with available images.¿ there does appear to be thrombus within the thoracic aorta on the post-implantation images from the arch to dta, however, contrast cannot be identified in a ¿false lumen¿.Probable dissection.The thrombus or dissection extends distal to the distal end of the implanted device.Cannot confirm that this was not present on pre-implantation imaging/drawings.¿ cannot confirm a dissection on the angiogram post-implantation jpeg image according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, aortic expansion, dissection, fistula 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) 2024, additional surgical procedure was performed to treat the aortoesophageal fistula.To discontinue the traffic between the false lumen and the esophagus, the enlarged false lumen was resected and the outer membrane was sewn onto the ctag/ac devices.The patient tolerated the procedure.

• 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: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19150156
• MDR Text Key: 340678291
• Report Number: 2017233-2024-04855
• 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: 04/22/2024

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: TGMR312610J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2023
• 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: 79 YR
• Patient Sex: Female