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 TGMR404010W

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

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 oct 30, 2023, a patient was implanted gore® tag® conformable thoracic stent graft with active control system (tgmr404010w, tagac device) bridging with tgmr343410w to treat thoracic aneurysm.The tgmr404010w was advanced via 22fr.Dryseal sheath to target lesion.After the physician actuated the primary deployment handle, the stent expanded to intermediate diameter.After every deployment line was pulled out, the stent opened a bit.However, it wasn't fully expanded.Finally, the physician used 14mm and 16mm pta balloon to inflate cads device.The stent was opened to full diameter.The patient tolerated the procedure and didn't experience any adverse event.

Manufacturer Narrative

H6: c19- a review of the manufacturing records indicated the lot met all pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: twelve movie clips received for evaluation: pre-implantation images do not show the date of acquisition.Intra-operative movie clips are date on (b)(6) 2023.There appears to be an isolated lesion in the distal aortic arch on the pre-implantation movie clip.Intra-operative angiogram images show a fully deployed ctag in the proximal to mid descending thoracic aorta (dta).A second ctag is extending proximally from within the first implanted device.Both ends of the 2nd device appear to be partially expanded with a non-expanded central portion of the device.Multiple attempts to balloon the proximal and distal ends of the 2nd device are shown.Final angiogram run shows both ctag devices are fully expanded.There appears to be flow throughout both implanted devices.The stent remains implanted.The device was received on 11/13/2023 and device evaluation showed the following: the primary deployment line (pdl) that remained connected to the primary deployment knob measured approximately 153cm long.This is comparable to the approximate 156.5cm pdl attached to the deployment knob of a fully deployed primary sleeve on a separate representative 40x40x10 device.The secondary deployment line (sdl) that remained connected to the secondary deployment knob measured approximately 144cm.This is comparable to the approximate 140cm sdl attached to the deployment knob of a fully deployed secondary sleeve on a separate representative 40x40x10 device.Based on the imaging evaluation, both ends of the 2nd device appear to be partially expanded with a less expanded central portion of the device confirming the report the device not fully expanding.No root cause for the stent graft not deploying to full diameter could be identified.No manufacturing deficiencies were identified during the device evaluation.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18108450
• MDR Text Key: 329115662
• Report Number: 2017233-2023-04396
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TGMR404010W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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
• Treatment: COOK LANDERQUEST 0.035INCH 260CM STIFF WIRE, 22FR.
• Patient Age: 50 YR
• Patient Sex: Male