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

Catalog Number	CXT321414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
The following was reported to gore: on (b)(6) 2025, patient underwent an endovascular aneurysm repair (evar) procedure utilizing a gore® excluder® conformable aaa endoprosthesis.Reportedly, there was device failure with the plastic sheath breaking off inside patient.On november 03, 2025, additional information received: physician notice a small piece of the nose cone was missing when he removed the delivery system post evar procedure (no resistance felt).Case was successfully completed and they could not visualize the piece under imaging.They are not sure if the piece was missing before it went into patient.Patient is doing well with no issues reported.1600-e:-catheter events - other/unknown is used to capture the missing nose cone.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h3 and h6.Engineering evaluation summary: the device evaluation performed by engineering showed the following: ¿ no damage was observed on the leading end of the returned catheter.¿ the image from the field indicates the area in question is an intentional cut within the catheter created during manufacturing to allow the constraining loop and lock mandrel to exit the catheter.Based on the findings from the evaluation the reported observation that a piece of the nose cone was missing could not be confirmed.
Additional Manufacturer Narrative
Added g3, g4, h1, h2, h6 and h7.Additional investigation determined no product problem, malfunction or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 3007284313-2025-04395 was submitted in error and is hereby retracted.Review of the file determined this event to be non-reportable, as no patient adverse events, malfunction or other serious injury has been reported.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Common Device Name: 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23639787
• Report Number: 3007284313-2025-04395
• Device Sequence Number: 9848995
• Product Code: MIH
• UDI-Device Identifier: 00733132651061
• UDI-Public: (01)00733132651061(17)271020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CXT321414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 02/02/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown