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

Model Number	RMT281216
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that on (b)(6) 2012, the patient presented with an abdominal aortic aneurysm and was treated with a gore® excluder® aaa endoprosthesis.It was stated that on (b)(6) 2022 the endoprostheses was explanted due to type ii endoleak.The patient's outcome is unknown.
Additional Manufacturer Narrative
No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Other code: the medical device returned to a third party for further investigation.The analysis report was shared with gore and evaluated appropriately.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.
Event or Problem Description
It was reported to gore that on (b)(6) 2012, the patient presented with an abdominal aortic aneurysm and was treated with a gore® excluder® aaa endoprosthesis.Endoleak was detected in (b)(6) 2020.Aneurysm growth is reported as 2cm in one year.It was stated that on (b)(6) 2022, the endoprostheses was explanted due to type ii endoleak which perfused the lumbar arteries.No harm to the patient.
Additional Manufacturer Narrative
Cause investigation and conclusion: additional information to the event has been requested from the third party and were provided.The provided information was captured in the event description.A review of the manufacturing records indicated the lots met all pre-release manufacturing specifications.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.Considering the nature of this event and the results of this investigation, this occurrence did not warrant remedial, corrective or preventative action in addition to no field safety action.The risk management documents for the gore® excluder® aaa endoprosthesis were reviewed.No potential new or different reasonably foreseeable risk related to the device or its use were identified based on this event.The benefit of the product has been assessed against the overall residual risk and determined that the benefit of the product outweighs the risk to the patient.Ongoing risk/benefit assessment and acceptability of residual risk serves to reaffirm risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore monitors complaints closely to ensure that risks remain within the bounds estimated in the risk management documents.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kerstin haberländer ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16311920
• Report Number: 2017233-2023-03693
• Device Sequence Number: 17843263
• Product Code: MIH
• UDI-Device Identifier: 00733132610686
• UDI-Public: 00733132610686
• 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: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Expiration Date: 03/31/2015
• Device Model Number: RMT281216
• Device Catalogue Number: RMT281216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2012
• 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 Age: 71 YR
• Patient Sex: Female