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 TGM454520J

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The actual event date is unknown.Therefore, (b)(6) 2020 is used as the event date.Code "other" was selected as the medical device remains implanted.Return not possible.According to the gore® tag® conformable thoracic stent graft with active control system for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), endoleak, migration.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, a stent graft which was a potential for a gore® tag® conformable thoracic stent graft with active control system was implanted (details unknown).On (b)(6) 2020, a reintervention was performed.A gore® tag® conformable thoracic stent graft with active control system was implanted distally of the previous implanted device which was potential for the gore® tag® conformable thoracic stent graft with active control system.It is unknown why this reintervention was performed.(this event was captured in medwatch report number 2017233-2024-04860).During a follow-up, an aneurysm in a thoracoabdominal was enlarged gradually.On an unknown date, the gore® tag® conformable thoracic stent graft with active control system which was implanted on (b)(6) 2020 moved proximally (distance unknown) and a distal type i endoleak and the aneurysm enlargement (amount unknown) were confirmed.On (b)(6) 2024, a reintervention was performed.The first gore® tag® conformable thoracic stent graft with active control system was implanted distally.However, an angiography revealed the endoleak remained.The second gore® tag® conformable thoracic stent graft with active control system was implanted and the endoleak was resolved.The patient tolerated the procedure.

Manufacturer Narrative

H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code c21 was updated to code c19.

• 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19188640
• MDR Text Key: 341116886
• Report Number: 2017233-2024-04873
• 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: 05/10/2024

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 Expiration Date: 05/27/2023
• Device Catalogue Number: TGM454520J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male