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 TGMR373720J

Device Problems Positioning Problem (3009); Unintended Movement (3026); Insufficient Information (3190); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.: code c20: results pending completion of investigation.H.6.: code b22: results pending completion of investigation.H.6.: code a26: results pending completion of investigation.H.6.: code e2402: results pending completion of investigation.H.6.: code d16: results pending completion of investigation.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

The following was reported to gore; on an unknown date, this patient underwent total arch replacement and partial replacement of the descending aorta.On an unknown date, proximal anastomotic aneurysm of the graft in the descending aorta was observed.On (b)(6) 2023, the patient underwent endovascular treatment of the anastomotic aneurysm using conformable gore® tag® thoracic stent graft with active control system.The stent grafts were to be implanted to cover from the proximal anastomosis to the distal anastomosis of the graft.A tgmr373720j was implanted at the target site and when the delivery catheter was pulled after the angulation assembly handle was removed, the olive tip of the catheter behaved as if it was caught on the tip of the tgmr373720j stent graft and could not be removed.The delivery catheter was rotated, and pulling with the stiff wire removed was also attempted, but it was not successful.An attempt to create a pull-through wire was made, but a guide wire could not be inserted into the delivery catheter (and therefore, damage in the wire lumen was suspected).Without a guidewire, when pulling the delivery catheter with strong force, it was able to be removed, but the proximal part of the tgmr373720j stent graft moved inward like it was turning down, causing migration.Because of the migration, a proximal type i endoleak was observed.To repair the endoleak, an additional stent graft (tgmr404020j) was to be implanted proximally.After creating a pull-through wire, the tgmr404020j was delivered.During delivery of the tgmr404020j, it was observed that the stent strut of the tgmr373720j was partially came off/detached (not separated) from the graft material, and moved up to above the proximal end of the tgmr373720j with the tgmr404020j delivery catheter.It was reported that the detached part was thought to be the proximal portion (pus or stent wire below the pus) that had become folded inward.The detached stent wire was placed between the patient's vessel and the tgmr404020j stent graft.The procedure was completed after confirming that the endoleak was resolved.The reported device will be returned to gore for further investigation.

Manufacturer Narrative

H3: imaging evaluation: summary: the imaging evaluation performed by a clinical imaging specialist showed the following: two short intra-operative angiogram video clips without dates available for evaluation.Video #1 shows: abnormal stent patterns in the proximal portion of the device.The device on this image is more distal than the devices on video #2.Proximal portion of device appears to be located at a level between the 3rd and 4th sternal wires.Cannot confirm an endoleak without contrast.Video #2 shows: there is an additional implanted ctag device extending proximally from the first implanted device.The proximal portion of the 2nd device appears to be located at a level between the 2nd and 3rd sternal wires.The proximal stent patterns of the 2nd implanted device appear to be normal.Cannot confirm full expansion of the distal portion of the implanted devices with available imaging.

Manufacturer Narrative

H3: the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the lockwire handle and angulation handle were returned attached to the white handle component.The lockwire and angulation fibers were properly routed through the catheter transition.These observations do not support the physician¿s report that the catheter was pulled after the angulation handle was removed.The lockwire was not returned routed through the skives or olive.The device evaluation showed damage to the skive and catheter transition, and the lockwire was returned coiled.The reported event of detached stent wire could not be confirmed as the stent graft was not returned for evaluation.Fluoroscopic videos of the procedure were returned for evaluation.The videos showed abnormalities with the stent graft at the proximal end, and the device migrated distally from the target site.These observations support the physician¿s report of device migration and abnormalities with the stent graft at the proximal end.The evaluation of the device and videos confirm the reported failure mode of catheter withdrawal interference.The root cause for catheter withdrawal interference and the observation of device migration and abnormalities with the stent graft at the proximal end is most likely attributed to the lockwire not being removed.The reason for failure to remove lockwire cannot be determined with the available information.No manufacturing deficiency were identified during the device evaluation.Therefore, no capa request is required.Events will continue to be monitored per md24024.H6: code a 26 updated to a0512.H6: code b22 updated to b19 and b14.H6: code c20 updated to c19.H6: investigation conclusions: code d16 updated to code d15 and code d1102 and code d12.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications may include, but are not limited to: endoleak, stent graft: improper placement; incomplete deployment; migration; material failure.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17933166
• MDR Text Key: 325636443
• Report Number: 2017233-2023-04331
• 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,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TGMR373720J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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 Age: 91 YR
• Patient Sex: Male