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

Model Number	RLT311417
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2016, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprostheses (rlt311417 and plc181000).Computed tomography (ct) imaging on (b)(6), 2016, showed that the maximum diameter of the aortic aneurysm measured 47 mm.Maximum aortic aneurysm diameter increased to 60 mm as measured with ct imaging on (b)(6) 2023.On (b)(6) 2023, the implanted devices were explanted due to aneurysm growth and type iii endoleak caused by a faulty connection between the device placed in the left iliac branch (plc181000) and the aortic main body (rlt311417).
Additional Manufacturer Narrative
D10 - concomitant medical product: gore® excluder® aaa endoprosthesis (catalog plc181000, serial number (b)(6)).H6-code b13: a request was emailed to the study coordinator to provide additional information like, details of the onset procedure, patient condition, and initial device overlap.Furthermore, images of the case and the explanted device were requested for return.The answer is pending.H6-code b14 and c19: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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
Cause investigation and conclusion: requests were emailed to the study coordinator to provide additional information like, details of the onset procedure, patient condition, and initial device overlap.Furthermore, images of the case and the explanted device were requested for return.The requests remained unanswered.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.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.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17133399
• Report Number: 3007284313-2023-02556
• Device Sequence Number: 20463927
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 09/14/2018
• Device Model Number: RLT311417
• Device Catalogue Number: RLT311417
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 82 KG