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 TGMR373715

Device Problem Patient-Device Incompatibility (2682)

Event Date 03/30/2024

Event Type  Injury  

Event Description

The fsa reported the following to gore: on (b)(6) 2024, the patient underwent an endovascular procedure in zone 2- lcc to treat an symptomatic intramural hematoma and aneurysm utilizing gore® tag® conformable thoracic stent graft with active control system endoprostheses.It was reported that the procedure was completed and everything looked good.After completion, the fsa left and was called back by the nurse because the physician stated that another piece needed to be placed.Once the fsa reentered the room, the physician stated that the patients pressure was dropping and that the 2nd graft placed (tgmr373715) had torn.The physician mentioned that they took a picture and there was blush.The physician already had a new device and was to cover what they thought was torn.However, when they put the new device in, upon deployment, it appeared that they were in between the two old grafts because the 3rd graft did not open completely.Due to the graft not opening completely, they decided to balloon it and it crushed the second graft which showed the fsa that they were in between the 2 grafts originally placed.Therefore, it could be that when they took their shot, they were not inside the graft.That is what made it appear that it was torn, possibly.There is no way now to confirm this unless the graft is explanted.The implanting physician believes the tearing of the graft caused a large type 3 endoleak.It was proven that the physician was in between the two grafts at some point.The fsa was not in the room during the entire procedure.When the fsa came back into the room, the physician had already taken pictures and already had wires up and the fsa wasn¿t able to observe the event until the graft deployed.It was then that the fsa was able to determine that the wires were not in the correct place.They had to put in two more pieces (tgmr373710 and tgmr404015) to cover up the torn graft.The patient tolerated the procedure.

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and / or require intervention include endoleak.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

H.6: code b15 - images were provided, and an imaging evaluation was performed.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.The imaging evaluation determined the following: two movies and 2 jpeg images were provided for evaluation.The movies could not be opened.The diameter or length measurements could not be taken on the jpeg images or movies.The first jpeg showed 2 ctag devices implanted with contrast outside the implanted devices; however, an endoleak type cannot be confirmed with the available images.The second jpeg shows an additional ctag implanted.The endoleak appears to be resolved.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19197934
• MDR Text Key: 341237272
• Report Number: 2017233-2024-04875
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646814
• UDI-Public: 00733132646814
• Combination Product (y/n): N
• 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: 05/07/2024

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 Catalogue Number: TGMR373715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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): Required Intervention
• Patient Age: 84 YR