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 TGMR404015

Device Problems Separation Failure (2547); Malposition of Device (2616)

Patient Problem Perforation of Vessels (2135)

Event Date 10/07/2023

Event Type  Injury  

Manufacturer Narrative

H6: code c20 - a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.H6: code d12 ¿ according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vessel trauma and improper component placement 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 was treated for a type a aortic dissection.As part of an elephant trunk procedure, the physician implanted a gore® tag® conformable thoracic stent graft with active control system.During deployment, the physician was unable to remove the lockwire pin handle.Eventually, the physician was able to use other methods to remove the lockwire, and the device was successfully deployed.It was then seen that the device had been deployed into the false lumen and caused further trauma to the pre-existing dissection.Using ivus, the physician extended the gore® tag® conformable thoracic stent graft with active control system both proximally and distally with additional gore® tag® conformable thoracic stent graft with active control system devices.The proximal device extended from the true lumen through the entry tear in the vessel to the proximal end of the device in the false lumen, and the distal device extended from the distal end of the device in the false lumen through a reentry tear into the true lumen.The dissection was sealed, and the patient tolerated the procedure.

Manufacturer Narrative

B1 updated to adverse event.

Manufacturer Narrative

H1/h2 type of reportable event: malfunction updated to serious injury.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18067069
• MDR Text Key: 327309062
• Report Number: 2017233-2023-04379
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/12/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TGMR404015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/07/2023; 12/08/2023
• Supplement Dates FDA Received: 12/07/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Male