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

Catalog Number	CXT231412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, the patient underwent an endovascular procedure, to treat an aneurysm, utilizing gore® excluder® conformable aaa endoprosthesis and gore® dryseal flex introducer sheath (dsf1633 serial# is unknown).It was reported during the procedure, after the graft was successfully deployed, upon removing the delivery catheter of the conformable device, the physician could not remove it through the tip of the dsf1633 dryseal sheath.The nose cone of the delivery catheter could not pass through the sheath.The physician attempted to use some extra force, but the delivery catheter still could not be removed.It was also reported, physician decided to remove both the conformable device and the sheath all at once, pulling both out at the same time, with the nose cone portion remaining outside of the sheath.Upon removal of the conformable delivery catheter, a portion of the catheter appeared missing.The physician then cut the valve portion of the sheath off in an attempt to find this missing piece inside the sheath.No fragment was found in the sheath.A post angiogram was performed, and no fragment was seen inside the patient.No further issues were noted, and the patient tolerated the procedure.As per the physician, the cause of this issue remains unknown.1600-e:-catheter events - other/unknown-used to capture missing fragment noted on catheter.
Additional Manufacturer Narrative
H6: code b21- device en route but is not yet arrived at facility h6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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.
Additional Manufacturer Narrative
Updated section h7, and h10.The device was returned and showed the following: the reported device failure mode, a portion of the catheter appeared missing, could not be independently confirmed through an evaluation of the returned device and provided photo.The portion of the delivery catheter that appears missing is an intentional skive cut that is done as part of the manufacturing process.The skive cut allows the constraining loop and lock mandrel to exit the catheter at the leading end.After further evaluation of this event, it was determined this event is not reportable as there was no catheter fracture noted during engineering analysis.This medwatch report shall be retracted.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23059782
• Report Number: 3007284313-2025-04252
• Device Sequence Number: 15873423
• Product Code: MIH
• UDI-Device Identifier: 00733132651016
• UDI-Public: (01)00733132651016(17)280618
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/25/2025

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: CXT231412
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2025
• 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 Age: 63 YR
• Patient Sex: Unknown