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

Catalog Number CXT261412

Device Problems Patient-Device Incompatibility (2682); Unintended Movement (3026)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

H.6.: code e0518: used to capture that the 3rd stent got distorted; however, no obstruction on the blood flow due to the distort was observed on the angiography.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 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.Renal (e.G., artery occlusion, contrast toxicity, insufficiency, failure) and endoleak.According to the gore® excluder® conformable aaa endoprosthesis instructions for use, implant procedure: do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential patient harms.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) 2023, this patient underwent an endovascular treatment of an abdominal aortic aneurysm enlargement due to failure of the proximal and distal anastomoses of the pre-existing y-graft using gore® excluder® conformable aortic extender endoprosthesis.The preoperative plan was that after partially deploy the trunk-ipsilateral leg component, it will be moved down to just below the left renal artery.During the procedure, after the deployment knob was pulled, the physician removed the secondary sleeve deployment line from the access hatch to deploy the trunk body, and then attempt was made to move down the device but due to the tortuous of the aorta, the device could not be moved down.A hand-made snare was inserted and grasped the ipsilateral leg, upon pulling down the snare and delivery catheter together to attempt to move the trunk-ipsilateral leg component down, the delivery catheter was detached from the proximal edge of the stent graft, that resulting the 3rd stent got distorted; however, no obstruction on the blood flow due to the distort was observed on the angiography, no repair was performed.The final angiography revealed that the left renal artery was partially unintentionally covered because the reposition of the trunk-ipsilateral leg component was not successful.And also a proximal type i endoleak was observed, it will monitored.The procedure was completed without further treatment and the patient tolerated the procedure.The physician reported a possibility that it might have been better to place the device just below the left renal artery from the beginning and push up the contralateral gate, assuming that the device could not be moved down.

• 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: 17952360
• MDR Text Key: 325898313
• Report Number: 3007284313-2023-02831
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: 00733132651030
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CXT261412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Date Device Manufactured: 06/08/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Female