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

Catalog Number	PLC121400
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, the patient presented to emergency room for an emergent aneurysm rupture in an endovascular procedure utilizing a 15fr gore® dryseal flex introducer sheath and gore® excluder® conformable aaa endoprosthesis.Reportedly, the 15fr sheath was used for the ipsilateral side in order to place the 23mm trunk ipsilateral leg conformable.The graft was deployed fully, however, when trying to remove the catheter, the olive tip broke off as it caught on the sheath.Fortunately, physician was able to snare the olive tip back into the sheath with no harm to patient (no piece left inside) and replaced the sheath with a 16fr sheath to continue the procedure.The patient's iliacs were noted to be tortuous and at end of procedure, there was a type 1a endoleak which physician attempted to fix by adding an aortic extender but it did not fix the problem.At this point, physician tried to place endo anchors into the graft, however, physician was only able to place one endoanchor when patient's pressures started to worsen and they had to open the patient's abdomen.After they suctioned out the patient¿s belly, they went back in and tried to place the other endo anchors and realized the contralateral limb popped out (disconnected) from the main body.At the same time, the patient started to deteriorate rapidly and ended up passing away due to the ruptured aneurysm.Physician stated there were no device related complications that led to the patient¿s death as its due to the emergent aneurysm rupture they were treating and the patient was in horrible condition at baseline.However, they had already opened the patient¿s abdomen before the limb disconnected, which physician said is likely due to the manipulations from the anchor catheter and from opening the belly while moving the aorta around.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.H6: d15 code: there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device." 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
Additional investigation determined no product problem 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 3013164176-2025-02602 was submitted in error and is hereby retracted.

• Brand Name: GORE® EXCLUDER® 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22493045
• Report Number: 3013164176-2025-02602
• Device Sequence Number: 7940776
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: (01)00733132618644(17)271125
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• 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): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PLC121400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female