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

Catalog Number	RLT281412
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by gore that on (b)(6) 2025 a patient underwent an endovascular abdominal aneurysm repair with a gore® excluder® aaa endoprosthesis device (rlt281412) and gore® excluder® aaa endoprosthesis - contralateral leg (plc) devices.The field sales associate (fsa) reported that the physician released the rlt excluder main body and deployment of the ipsilateral leg was finished on the right side.Then, he proceeded with the plc (sn: (b)(6)) delivery system to cannulate on the left side and pushed the plc catheter upwards.This plc catheter was advanced without a sheath (unknown reason why sheath was not used) and advanced via access vessel proximally to the trunk.The physician wanted to proceed rapidly to advance the plc catheter into the contralateral gate of the main body and the fsa could see that he processed very quickly to push the plc catheter inside.Eventually, he could finish the leg's gate cannulation, but this quick action has lifted the whole trunk above the left renal artery.The plc could be deployed at this stage.Subsequently, the physician decided to use an extra bentley stent (7 mm) for the left renal artery and had to maintain the blood flow.Also, he tried to use specific tip shapes at the covered area of the proximal end of main body and could manage this placement.The new stent was placed in approx.10 minutes through the rlt wire frame apices and the physician assured a permanent perfusion into the left renal artery quickly.The procedure was completed without complications and both renal arteries were patent after that intervention.The patient tolerated the procedure.Additional information received, further it was noted by fsa that the physician didn't perform the apnea during imaging and the patient was still breathing continuously.Therefore, a correct positioning at the renal arteries was incomplete due to motion of the patient's chest.After that pushing activity with plc catheter (without a sheath), in a ct angiography it showed that the proximal marker of the trunk was at the upper position of the left renal artery.At this stage, repositioning of the main body was no longer feasible.Following a clinical discussion and in the absence of a viable bail-out strategy, it was determined that an additional stent (bentley, 7mm) could be deployed to maintain perfusion to the covered ostium of the left renal artery.Reportedly, the manipulation at the proximal end of the main body was necessary to place the bentley stent accordingly.There were potential perforations needed at the proximal end and the physician had used unknown techniques during the stenting process.All steps had no negative effect to the wall apposition at the deployed excluder main body with the plc and the procedure ended uneventful.No angiography images are provided for this final rlt deployed phase at infra-renal position.Also, no images from the moment when the plc was pushed into the contra-leg's gate are available.The aortic neck was measured at 3 cm in length.
Additional Manufacturer Narrative
Per gore reporting guidelines this medwatch submission has been created for the wrong device and needs to be retracted.However, this medwatch is saved in our quality system and the record is now created.The migration of the device rlt281412, serial: (b)(6) is not reportable, therefore this report can be ignored.No more updates (no follow-up report) therefore be planned.For the related event it has to complete investigation and will be completed for the other involved gore device: - plc, serial: (b)(6) (covered in gore ref id: (b)(4)).Gore continues to report on the reportable device in another submission reference, as required.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.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marcel martin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23622187
• Report Number: 3007284313-2025-04390
• Device Sequence Number: 10044986
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: (01)00733132622528(17)280511
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: RLT281412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male