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

Catalog Number RLT281416J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Aneurysm (1708)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak.Please note that the same patient was captured in medwatch report number 2017233-2024-04753.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 (b)(6) 2022, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2022, the patient underwent an endovascular treatment of a thoracic aortic aneurysm using two gore® tag® conformable thoracic stent graft with active control system (tgmr373710j and tgm343415j).Tgmr373710j was implanted distally.On (b)(6) 2024, the patient was raced to the hospital for an impending rupture.It was confirmed that the impending rupture of the descending thoracic aortic aneurysm due to a distal type i endoleak from the gore® tag® conformable thoracic stent graft with active control system.And a proximal type i endoleak from the gore® excluder® aaa endoprosthesis was also observed.On (b)(6) 2024, a reintervention was performed.A gore® viabahn® endoprosthesis with propaten bioactive surface was implanted in the left renal artery and the right renal artery.A gore® tag® conformable thoracic stent graft with active control system was implanted to connect the previous implanted gore® tag® conformable thoracic stent graft with active control system and gore® excluder® aaa endoprosthesis (trunk ipsilateral leg).The procedure was concluded and the patient tolerated the procedure.The physician stated that the diameter of the infrarenal artery enlarged about 30 mm from about 22 mm and the diameter of the artery near the superior mesenteric artery enlarged about 34 mm from about 25 mm within 2 years after the gore® excluder® aaa endoprostheses and the gore® tag® conformable thoracic stent graft with active control system were implanted and these arteries enlargement led the endoleaks.And the physician also reported that the patient vessel condition was not well due to advanced age and it might be one of cause of the neck enlargement.

Manufacturer Narrative

H6: replaced c21 with c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18984687
• MDR Text Key: 338659134
• Report Number: 3007284313-2024-03135
• 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: 04/02/2024

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 Catalogue Number: RLT281416J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: 91 YR
• Patient Sex: Female