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 TGM212110E

Device Problems Material Invagination (1336); Deformation Due to Compressive Stress (2889); Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3 other code, h6 code b20: the device remains implanted and therefore no product evaluation has been performed.The initial reporter has been contacted in order to receive more information on the event and patient details.Imaging have been requested from the physician.A review of patient imaging and product history records will be conducted once information provided.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

It was reported to gore that an emergency (thoracic endovascular aortic repair) tevar took place on (b)(6) 2024 using a gore® tag® conformable thoracic stent graft with active control system.Patient imaging showed that the device had infolded.The cause of the infolding is unknown.The device was reportedly not undersized.The physician used the angulation control though the patient anatomy was straight.

Event Description

It was reported to gore that an emergency (thoracic endovascular aortic repair) tevar took place on (b)(6) 2024 using a gore® tag® conformable thoracic stent graft with active control system.It was reported that the physician applied too much angulation control which caused the proximal end of the device to be under a large amount of tension in a straight anatomy.When the lock wire was released, this caused the top end of the device to ¿fold back¿ and the entire device to fall back by a couple of centimeters.It was reported by the physician that it was entirely operator error, and there is nothing wrong with the device.A second 26 mm gore® tag® conformable thoracic stent graft with active control system was used to extend the proximal part and this straightened out the infolding.Satisfactory outcome achieved.

Manufacturer Narrative

B5: event updated with new information received.D4: updated catalog number, serial number, expiration date, and unique identifier (udi) #.Additional information was provided by the physician.A user error caused the incident (infolding of the the proximal part of the device) which was corrected during procedure.The migration of the device also did not cause any injury to the patient (no vessel coverage or aneurysm growth).The reporting decision was re-evaluated based on the updated information.This incident no longer meets the criteria of a reportable incident, and if it occurred again, might not lead to death or serious deterioration in health.The manufacturer report number 2017233-2024-04812 is therefore retracted.As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.The device remains implanted in the patient.Therefore, a device evaluation could not be performed.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time-point is available for evaluation: intra-operative angiogram movie clips.¿ 4:35pm ¿ non-deployed device appears in the aortic arch/dta.The proximal end of the device appears to be near the proximal border of the left common carotid artery (lcca), on the projection provided.¿ 4:37pm - the device appears to be partially deployed and the proximal end is at the level of the left subclavian artery (lsa).¿ 4:43pm ¿ the wire pattern in the proximal end of the device appears to demonstrate the ¿folding back¿ of the device described by the physician.The proximal end of the device appears to be ~2cm+ distal to the lsa.There is flow throughout the device.¿ 4:56pm - there is a second device implanted within the original implanted device and extends proximally.The proximal end of the second device appears to be at the level of the distal border of the lcca, on the projection provided.There appears to be flow in the ascending thoracic aorta all three head vessels (brachiocephalic trunk artery (bca), lcca, lsa) post deployment of the second device.Both devices appear to be fully expanded.Per the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), deployment instructions cautions for: proximal angulation cannot be reversed or undone.Use the smallest amount necessary to achieve optimal graft alignment.In order to avoid over-angulation of the device, rotation of the angulation control dial should be slow and deliberate to achieve optimal graft alignment.B2, remove check box for other serious (important medical events).H6: updated health effect - clinical code (e2401 should be removed), updated health effect - impact code (f24 should be removed), updated medical device problem code (a040606 should be removed).Added b14 and b15.Updated investigation findings (c21 is no longer applicable), updated investigation conclusions (d16 is no longer applicable).

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19077545
• MDR Text Key: 339995757
• Report Number: 2017233-2024-04812
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: TGM212110E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other