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

Catalog Number	CXA360005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, patient underwent an emergent endovascular procedure to treat a ruptured aortic aneurysm utilizing a gore® excluder® conformable aaa endoprosthesis (conformable aortic extender).Reportedly, during the procedure, the conformable aortic extender broke off from the catheter upon attempted withdrawal into the 18fr sheath (non-gore) resulting in both the conformable aortic extender and the olive tip being snapped off from the catheter in the common iliac artery.Physician wanted to advance the sheath and was planning to pull the conformable aortic extender out of the body, so that he could re-engage the dilator into the sheath.After multiple hours of attempts, we had to leave both the pieces inside the patient.The conformable aortic extender was expanded in the common iliac artery using a non-compliant balloon (conquest) and the olive tip was endo trashed with another 12mm limb to trap it between two limbs.Another comfortable aortic extender was then used for the procedure from the left contralateral side and the first 18fr sheath (non-gore) was removed.A new 18fr sheath was used both on the right and left side to complete the procedure.The patient tolerated the procedure and was stable.
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.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Engineering evaluation summary: the device evaluation performed by engineering showed the following: the proximal end of the deployment fiber was observed to be undamaged.The proximal end of the catheter shows evidence of reflow where the leading tip was previously bonded.There was significant damage and stretching observed on the catheter from the transition bond to the inner member of the catheter.Based on the findings from the evaluation, the reported observation of ¿the olive tip being snapped off from the catheter¿ was confirmed.The evaluation performed by engineering determined that the state of the returned device is consistent with increased force being applied when removing the catheter, no manufacturing deficiency was identified.The cause for the leading olive and endoprosthesis separation may be attributed to a use error in withdrawing the undeployed device through the sheath as 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: 23704781
• Report Number: 3007284313-2025-04419
• Device Sequence Number: 16119879
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: (01)00733132650972(17)280713
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: CXA360005
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female