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 TGMR313115J

Device Problems Material Separation (1562); Activation Failure (3270)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent an emergency endovascular treatment of a traumatic thoracic aortic dissection using gore® tag® conformable thoracic stent graft with active control system (ctag-ac device).During implantation of a ctag-ac device, the primary deployment handle was pulled fully, but the stent graft was not deployed.The deployment line access hatch was opened, but there was no primary deployment line.The ctag-ac device was removed undeployed and the procedure was continued using another stent graft.No adverse events to the patient were reported.The physician reportedly stated as follows: when pulling the handle, there was a behavior like the leading olive was slightly pulled.

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 information was reported to gore: on (b)(6) 2023, this patient underwent an emergency endovascular treatment of a traumatic thoracic aortic dissection using gore® tag® conformable thoracic stent graft with active control system (ctag-ac device).During implantation of a ctag-ac device (tgmr313115j), the primary deployment handle was pulled fully, but the stent graft was not deployed.Subsequently, the secondary deployment handle was pulled fully, but again the stent graft was not deployed.The deployment line access hatch was opened, but there was no primary and seconary deployment lines.The tgmr313115j was removed undeployed and the procedure was continued using another stent graft (tgmr313120j).No adverse events to the patient were reported.The physician reportedly stated as follows: when pulling the primary deployment handle, there was a resistance (behavior like the leading olive was slightly pulled).There was no resistance when the secondary deployment handle was pulled.

Manufacturer Narrative

B5: describe event or problem: updated per additional information.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: codes a0413, b14: added to reflect results of investigation.H6: codes c19, d15, d12: updated to reflect results of investigation.H6: code d12: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events which may require intervention and/or conversion to open repair include, but are not limited to: access, delivery and deployment events (e.G.Access failure; deployment difficulties/failures; failure to deliver the stent graft; and insertion or removal difficulty), and stent graft: incomplete deployment the device evaluation showed the following: the fully constrained gore® tag® conformable thoracic stent graft with active control system device was returned for evaluation.The primary deployment line (pdl) was identified to be broken near the proximal end of the device, attached to the stent graft and sleeve.The pdl that remained connected to the primary deployment knob measured approximately 115cm.The observations of the device evaluation support the physician¿s report of the device not deploying during primary deployment.Based on the length of the returned secondary deployment line (sdl) that remained connected to the secondary deployment knob, there was no indication of an issue with the sdl.The device likely did not expand when the sdl was removed due to the device remaining constrained by the primary sleeve.The observations of the device evaluation support the physician¿s report of the device not expanding following secondary deployment.The core and outer wrap of the pdl fiber appear to have experienced tensile forces and are not indicative of a clean cut.Primary deployment not occurring is likely due to the pdl breaking.The pdl appears to have broken due to tensile forces.The root cause for the pdl breaking could not be confirmed with the currently available information.Based on the available information, there is no indication of a manufacturing deficiency.The imaging evaluation performed by a clinical imaging specialist showed the following: one short movie-angiogram clip provided for evaluation.No name, date, or demographics on the imaging.The first image of the angiogram movie shows a non-deployed device in the thoracic aorta.The second image shows motion as if pushing the deployment catheter forward toward the ascending thoracic aorta.The final image shows the non-deployed device is still undeployed on the deployment catheter.Cannot confirm actual deployment actions taken outside of the field of view on angiogram imaging.

• 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: mami nagashima ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18157758
• MDR Text Key: 328374122
• Report Number: 2017233-2023-04412
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TGMR313115J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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 Age: 78 YR
• Patient Sex: Female