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

Catalog Number	RLT311413
Medical Device Problem Codes	Difficult to Open or Close (2921); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, the patient was treated for a ruptured abdominal aortic aneurysm.While deploying a gore® excluder® aaa endoprosthesis rlt311413, the surgeon opened the device using the gray dial.The physician decided that he wanted to advance the device to a location slightly more proximal, so he turned the gray dial to reconstrain the device.When he used the dial to release the main body, the black nut stopped short of the end point.The physician was unable to get the red safety lock to pull back, and the gray dial would not turn any more.The physician intentionally broke the handle and pulled off the handle with wires attached.He was then able to complete deployment of the ipsilateral leg and remove the deployment catheter.The patient tolerated the procedure, and the deployment catheter was returned for evaluation.The physician believes the reconstraining mechanism did not operate properly.
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
H.6.Type of investigation code b01: the device evaluation showed the following: *engineering examined the returned components.The compression spring in the emds screw assembly had moved out of position from the trough of the bottom screw housing.*engineering observed that the screw assembly was received with the guide nut on the screw assembly in the fully unconstrained position.*engineering turned the screw knob on the screw assembly.The screw knob was able to be turned clockwise and counterclockwise, and the guide nut moved in the appropriate respective directions through the entire length of the screw assembly.*engineering was able to pull the lock button back and release the screw assembly from the spine adapter assembly without any resistance.Based on the findings from this evaluation, the physician¿s observation that ¿the black nut stopped short of the end point¿ was not confirmed.Based on the findings from this evaluation, the physician¿s observation that ¿the physician was unable to get the red safety lock to pull back, and the gray dial would not turn any more¿ was not confirmed.Based on the findings from this evaluation, the physician¿s observation that ¿the physician intentionally broke the handle and pulled off the handle with wires attached¿ was confirmed.H.6.Investigation conclusions code d15: 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.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19696973
• Report Number: 3007284313-2024-03362
• Device Sequence Number: 18175458
• Product Code: MIH
• UDI-Device Identifier: 00733132619078
• UDI-Public: 00733132619078
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/05/2024

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: RLT311413
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male