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

Catalog Number RLT261412J

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 09/27/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2016, this patient underwent an endovascular procedure for an abdominal aortic aneurysm (aaa) using gore® excluder® aaa endoprosthesis.After implanting all planned stent grafts, the final angiography confirmed a flow of contrast which was suspected to be a type ii endoleak, but not determined.No treatment was given, and the leak was left to be monitored.The patient tolerated the procedure.(captured in mpdcase-00015878).On an unknown date, the unknown amount of aaa enlargement has been confirmed.Also, the bilateral internal iliac arteries, which were untreated areas of the initially implanted gore devices, were found to have become aneurysmal.On (b)(6) 2023, a reintervention was performed.During the procedure, the physician noticed that the proximal sealing length of the implanted trunk - ipsilateral leg endoprosthesis (rlt261412j) has been shortened, therefore, a proximal type i endoleak was suspected to have contributed to the aneurysm enlargement.The intraoperative angiography confirmed no endoleak, however, it was decided to extend the proximal sealing length with an aortic extender endoprosthesis (pla280300j).During the deployment of the pla280300j, the device moved distally and landed about 6 mm distal to the intended location.The extension failed as both the proximal end of pla280300j and rlt261412j were located at the same level.The physician deployed another aortic extender endoprosthesis of the same size just below the lower renal artery, which was successfully placed and extended the proximal sealing length.The bilateral internal iliac artery aneurysms were treated by embolization of the vessels with distal extensions of stent grafts towards the external iliac arteries.The patient tolerated the procedure.

Manufacturer Narrative

H.6: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6: code b20: device remains implanted and therefore not available for direct analysis.H.6: code a27: used to capture the device having migrated distally after the procedure.The distance of migration is unknown.H.6: d12: according to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and or require intervention, include, but are not limited to, aneurysm enlargement and surgical conversion.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and improper component placement, and component 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.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18000117
• MDR Text Key: 326447773
• Report Number: 3007284313-2023-02854
• 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
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2019
• Device Catalogue Number: RLT261412J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Date Device Manufactured: 06/22/2016
• 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: 75 YR
• Patient Sex: Male