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

Catalog Number CXA360005

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2024

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2024, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis, and gore® excluder® aaa endoprosthesis.The trunk - ipsilateral leg endoprosthesis was deployed approximately 2 cm distal to the lower renal artery.When the aortic extender endoprosthesis was deployed on the proximal side, insufficient deployment was observed.Attempts were made to get full deployment using a balloon catheter or insert a wire into the gap, but these were unsuccessful.No endoleak was observed.The patient tolerated the procedure.

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use, 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.H6: the imaging evaluation performed by a clinical imaging specialist showed the following: three radiographic jpegs and one short angiogram movie provided for evaluation.Cannot manipulate the images in any way.(window level, rotate, etc.) jpeg images show a partial aortic extender deployment and attempted/unsuccessful ballooning to fully expand the aortic extender.Movie clip shows the deployment process.Partial deployment of the aortic extender.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

H6: according to the gore® excluder® conformable aaa endoprosthesis instructions for use, 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.Narrative: correction of ifu statement.

Manufacturer Narrative

Emdr section h6, codes b15 updated to reflect results of investigation.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: three radiographic jpegs and one short angiogram movie provided for evaluation.Cannot manipulate the images in any way.(window level, rotate, etc.) the movie clip appears to show a non-continuous (slow) deployment.An attempted ballooning failed to complete the expansion of the aortic extender.Movie clip shows the deployment process.Engineering evaluation summary: the complaint information reports that insufficient deployment of the aortic extender endoprosthesis was observed.The imaging evaluation of the images and movie clip of the deployment process appears to show the device being deployed in a non-continuous manner.The extender deploys from the trailing end to the leading end.The trailing end of the aortic extender opened at a sharp angle before the rest of the graft could open, and the trailing apices became stuck on the inner lumen of the previously implanted trunk-ipsilateral leg endoprosthesis.Upon fully releasing the aortic extender, the trailing end remained stuck on the inner lumen of the trunk.Based on the reported event description, ballooning was not able to address the irregular deployment of the graft; however, no endoleak was observed and the patient tolerated the procedure.Based on the images provided, the findings of the imaging evaluation are consistent with the physician¿s statement that there was ¿insufficient deployment observed¿.The root cause of the insufficient deployment could not be determined, though it is possible the non-continuous deployment contributed to the irregular deployment.

• 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: ayako yoshioka ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19161071
• MDR Text Key: 341476676
• Report Number: 3007284313-2024-03189
• 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,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXA360005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male