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 TGMR404020J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 09/03/2022

Event Type  Injury  

Event Description

On (b)(6) 2016, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis for bilateral internal iliac aneurysm.The right and left internal iliac arteries were embolized, and excluder limbs were placed from the right and left common iliac artery to the external iliac artery.Minor proximal type i endoleaks were identified bilaterally, but no specific treatment was performed.The patient tolerated the procedure.(captured in new case #(b)(4)).On (b)(6) 2022, this patient underwent endovascular treatment of a descending aorta aneurysm using gore® tag® conformable thoracic stent graft with active control system (ctag/ac).When the first ctag/ac was deployed proximally, the device migrated distally of intended position.Angiography confirmed that, after the second ctag/ac was deployed distally as planned, a proximal type i endoleak was revealed.Since the patient had shaggy aorta, the physician elected to place a additional stent graft instead of ballooning, and the endoleak was resolved.The patient tolerated the procedure.(captured by (b)(4)).Immediately after tevar, it was confirmed that the patient was able to move both legs.On (b)(6) 2022, 2 days after tevar, complete paraplegia was confirmed.Further information was not available.(captured by (b)(4)).

Manufacturer Narrative

Device evaluated by mfr: code "other" was selected as the medical device remains implanted.Return not possible.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.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16147197
• MDR Text Key: 307188698
• Report Number: 2017233-2023-03638
• 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
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TGMR404020J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male