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

Catalog Number CXA360005

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Renal Impairment (4499)

Event Date 11/17/2023

Event Type  Injury  

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 d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to: renal (e.G., artery occlusion, contrast toxicity, insufficiency, failure) improper component placement, and component migration h.6.: code d1102: according to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis or delivery system: improper component placement; incomplete component deployment; unintentional / premature component deployment; leading end catheter component retention; component migration; separation of graft material from stent; occlusion; infection; stent fracture; graft material failure, dilatation, erosion, puncture, perigraft flow.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 information was reported to gore: on (b)(6) 2015, this patient underwent emargency endovascular treatment for an imminent rupture of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A trunk - ipsilateral leg endoprosthesis (rlt261412j) was implanted from under the renal arteries.The patient tolerated the procedure.On an unknown date, migration of the rlt261412j to the distal side (distance: approximately 25 mm) was observed.On (b)(6) 2023, a reintervention was performed using gore® excluder® conformable aaa endoprosthesis.Aortic extender endoprosthesis (cxa360005) was to be implanted proximally to the migrated rlt261412j overlapping 2cm.However, during deployment of the cxa360005 from under the renal artery, it moved to proximally, resulting partial coverage of the right renal artery.Reportedly, the physician deployed the cxa360005 slowly (slow deploy).Also it was reported that the cxa360005, which began slowly deploying from one side of the distal (cxa360005 is deployed from distal one side, so usually it looked as if it was temporarily lifted one side), hit the rlt261412j during full deployment, causing it to jamp proximally.Because the deployment position of the cxa360005 was moved proximally, resulting in a shortened overlap with the rlt261412j, a second aortic extender endoprosthesis (cxa360005) was to be additionally implanted.When the second cxa360005 was deployed, the landing position of the left distal side became proximal than expected, and the distal side of the second cxa360005 was deployed at an angle.Therefore, a third aortic extender endoprosthesis (pla360400j) was additionally implanted.An attempt was made to implant an additional stent to treat the partial coverage of the right renal artery, but cannulation to the right renal artery was unsuccessful, so the procedure was completed with no treatment for the right renal artery coverage.There was no delay in blood flow to the right renal artery.On (b)(6) 2023, the patient's renal function declined, and an emargency reintervention was performed.However, cannulation to the right renal artery was unsuccessful again, the procedure was terminated without any treatment.The patient developed right renal failure and was placed on dialysis.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: 18344730
• MDR Text Key: 330721821
• Report Number: 3007284313-2023-02952
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: 00733132650972
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CXA360005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Date Device Manufactured: 02/28/2023
• 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): Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male