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 TGM343420J

Device Problem Difficult or Delayed Positioning (1157)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

As gore was unable to determine which gore® tag® thoracic component was involved in the alleged type ia endoleak, an additional gore® tag® thoracic component (tgm343420j/ (b)(4)) will also be identified on this report.Results pending completion of manufacturing evaluation.The device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® tag® conformable thoracic stent grafts with active control system instructions for use, complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, improper stent graft placement, and 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.

Event Description

On (b)(6) 2022, the patient underwent thoracic endovascular aortic repair of a thoracic descending aortic aneurysm using two gore® tag® conformable thoracic stent grafts with active control system.Prior to the procedure, 1-debranching axillary-axillary artery bypass using a gore® propaten® vascular graft (propaten graft) was performed.During the procedure, it was reported the proximal gore® tag® device did not have adequate apposition to the vessel wall at the greater aortic curve, and an intra-operative angiograph showed a proximal type i endoleak-like finding.When touch-up ballooning was performed at the proximal end of the gore® tag® device, the device reportedly migrated distally (distance not reported).As a result, the partially uncovered stent of the gore® tag® device was positioned just below the left subclavian artery (lsa).According to the report, progressive flow to the lsa remained, and the partially uncovered stent at the lesser aortic curve had lost some apposition to the vessel wall.The type i endoleak was confirmed to be resolved, and no treatment was performed for the migration.On (b)(6) 2022, follow-up computed tomography confirmed proximal type i endoleak and occlusion of the propaten graft.It was reported the occlusion was due to antegrade flow into the lsa.On (b)(6) 2022, the patient underwent a re-intervention procedure.A new 2-debranching axillary-axillary- left common carotid artery bypass was performed because of the initial bypass occlusion.The lsa was embolized, and an additional gore® tag® device was implanted proximally.The type i endoleak was resolved, and the patient tolerated the procedure.

Manufacturer Narrative

H6: code c19 ¿ a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.It should be noted that, per the gore® tag® conformable thoracic stent grafts with active control system instructions for use, complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, improper stent graft placement, and endoleak.As gore was unable to determine which gore® tag® thoracic component was involved in the alleged type ia endoleak, an additional gore® tag® thoracic component (tgm343420j/ (b)(6); udi # (b)(4)) will also be identified on this report.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15914880
• MDR Text Key: 304793444
• Report Number: 2017233-2022-03536
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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 Operator: Health Professional
• Device Catalogue Number: TGM343420J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female