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

Catalog Number CXA280005

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of manufacturing records for the device verified that the lot met all pre-release specifications.H6: code b15: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ three jpeg images provided for evaluation.¿ no name, date, or demographics on the images.¿ cannot manipulate the images in any way.(window leveling, rotating, etc.) ¿ first image is an angiogram with contrast and appears to show the proximal end of the device is not laying perpendicular to the aorta.Cannot identify any covered vessels on this image.¿ the second jpeg shows ballooning at the proximal end of the device(s).¿ the last image is of poor quality.Cannot confirm is there is an endoleak without contrast.Cannot confirm there is an aortic extender at the proximal end of the device.(difficult to see proximal device radiopaque markers with image provided.) ¿ there does appear to be a change in wire pattern within the implanted device(s) on the last image, however, cannot confirm a device infolding with available images or compression.H6: code d12: according to the gore® excluder® aaa endoprosthesis instruction for use (ifu), the potential adverse events with the use of device may include but are not limited to: incomplete component deployment.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) 2024, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis with active control system.During the deployment of an aortic extender endoprosthesis(cxa280005), the distal end of device infolded and one of distal anchors was positioned vertically against the left side of the vessel wall.The physician performed a ballooning within the expanded cxa280005 which successfully restored the shape of the device.No adverse effects to patient were reported.The patient tolerated the procedure.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: aya shinoda ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19141608
• MDR Text Key: 340569910
• Report Number: 3013164176-2024-02043
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132650958
• UDI-Public: 00733132650958
• 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: 04/19/2024

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: CXA280005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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: 88 YR
• Patient Sex: Male