MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER®AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number PLA360400J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/04/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the patient underwent the patient underwent an endovascular treatment of closure of a re-entry at the brachiocephalic artery using three gore® excluder® aaa endoprostheses.The patient had been undergone ascending aorta replacement for treatment of a type a dissection.On (b)(6) 2020, the patient underwent an endovascular treatment of closure of a re-entry at the distal descending aorta using gore® tag® conformable thoracic stent graft with active control system.On an unknown date, the ascending aorta to the arch aorta was enlarged.A total arch replacement and a frozen elephant trunk (fet) was performed.All aorta extender endoprostheses were explanted.As of(b)(6) 2022, with additional fsa provided information, the cause of the ascending aorta to the arch aorta enlargement is unknown.On (b)(6) 2022, it was observed that a part of the distal end of the fet was broken.A part of the elephant trunk had severe stenosis due to the pressure of the false lumen, because the radial force of the elephant trunk was lost due to the fet was broken (this is not gore device related event).It was observed, the vessel diameter of from the descending aorta to entire thoracoabdominal aorta was enlarged.Tevar was performed to treat the broken of the et.Two gore® tag® conformable thoracic stent grafts with active control system were implanted from the anastomosis of the total arch replacement to the initial gore® tag® conformable thoracic stent grafts with active control system.The physician decided to monitor the enlargement of vessel diameter of from the descending aorta to entire thoracoabdominal aorta.As of (b)(6) 2022, the cause of the enlargement of vessel diameter from the descending aorta to entire thoracoabdominal aorta is the blood flow from the re-entry in the thoracoabdominal remained, but this re-entry is located outside of the ctag treatment area.The physician stated that the vessel diameter was enlarged gradually as the blood flow from the re-entry in the thoracoabdominal area remained.Reportedly, the vessel diameter in the treatment area of the initial gore® tag® conformable thoracic stent graft with active control system was enlarged over 5mm from (b)(6) 2020 to (b)(6) 2022.

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.

Manufacturer Narrative

H.6.Type of investigation; added b14: analysis of production records.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation findings: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• Brand Name: GORE® EXCLUDER®AAA ENDOPROSTHESIS
• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15638219
• MDR Text Key: 302064756
• Report Number: 3013164176-2022-01514
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Catalogue Number: PLA360400J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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: 65 YR
• Patient Sex: Male