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 TGM343415E

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2023

Event Type  Injury  

Manufacturer Narrative

H6: code c21- a review of the manufacturing records for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for analysis.Images were sent to gore for investigation.Further information will be provided.Please note the tgm454515e/(b)(6) related with the partially coverage of the celiac trunk was reported separately.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 endovascular procedure using gore® tag® conformable thoracic stent grafts with active control system to treat a thoracic aortic aneurysm.The tgm343415e/(b)(6) was deployed.Reportedly, when the physician removed the catheter, it was noticed that the leading olive was missing, and it was inside the lunderquist.The physician continued the procedure and implanted tgmr373715e without any complications.It was reported that at the end of the procedure, the physician tried to retrieve the olive with a snare technique without success and it was necessary to implant a tgm454515e/(b)(6) to capture the olive between the aorta and the ctag device.During the implanting, the tgm454515e device partially covered the celiac trunk because the physician deployed the ctag quickly to be sure to capture the olive.The patient tolerated the procedure and was monitoring by the physician.It was reported that the physician did not feel any resistance advancing the device.The physician does not know what caused the olive separation.

Manufacturer Narrative

B6: imaging evaluation was added.H6: code c19- a review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Code c22 was used to cover that it was noticed by imaging a foreign body, likely the reported olive tip, moving within the aorta, however, gore cannot make conclusions due to the images received for evaluation.It was reported that the physician did not feel any resistance advancing the device.The physician does not know what caused the olive separation.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to catheter breakage and reoperation.Please note the tgm454515e/27288817 related with the partially coverage of the celiac trunk was reported separately.

Manufacturer Narrative

Corrected conclusion code in section h6.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18441382
• MDR Text Key: 331866017
• Report Number: 2017233-2024-04520
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/24/2024

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: TGM343415E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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; Hospitalization; Other
• Patient Sex: Female