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

Model Number	PLC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2023, the patient underwent reintervention whereby gore® excluder® iliac branch endoprostheses (ibe) were used to extend the 20mm contralateral leg component, located on the patient's left side.Reportedly, there was no observed issue with the contralateral leg component, and no observed distal type i endoleak.The aneurysm sac had reportedly grown from 3cm to 12cm in 8 months, and the physician wanted to reinforce the left limb in case a conversion was required at a later date due to sac growth.It was also observed that the contralateral leg component did not extend all the way down to the patient's left internal iliac artery, and therefore the physician opted to implant the ibe devices.There was reportedly no visible cause for the aneurysm growth.The patient tolerated the reintervention.There were no further reported issues.
Additional Manufacturer Narrative
Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.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.Investigation findings: code c19 - the imaging evaluation, performed by a clinical imaging specialist, showed the following: on the non-contrast, arterial and delayed ct¿s, there is an unknown density visible on all 3 phases.The length of seal in the left common iliac artery appears to be 31 mm and the length from the distal end of the device to the left iliac bifurcation appears to be 46 mm.Unable to confirm an endoleak or aneurysmal growth.H.6.Investigation conclusions: code d16 remains unchanged h.6.Investigation findings for analysis of data provided by user/third party: code c21 updated to code c19.
Additional Manufacturer Narrative
H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, aneurysm enlargement.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16486908
• Report Number: 3013164176-2023-01631
• Device Sequence Number: 5899891
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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: 05/10/2018
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 05/02/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/07/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male