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

Model Number	PLC271400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2013, the patient underwent an evar procedure utilizing five gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 -rmt261418, contralateral leg - pxc121400 & plc271400, iliac extender - pxl161407 and aortic extender - pla320400).On (b)(6) 2023, the patient underwent an endovascular reintervention in zone 11 - internal/external iliac to realign existing grafts utilizing gore® excluder® aaa endoprosthesis (stent graft contralateral leg - plc141400 and plc121200) to extend distally the left limb of the graft from the gate ring to the external iliac (left).There were no complications, and the patient¿s aneurysm is growing but there is no type 1a/1b, 2, or 3 endoleak that can be visualized on the cta or angiogram.The physician extended the left side because he thought it was a potential endoleak site that was not being observed.The patient tolerated the procedure.Reportedly, the patient was seen for follow-ups once a year (dates unknown) prior to reintervention on (b)(6) 2023, and will have a 3-month follow up after the reintervention (date unknown).
Additional Manufacturer Narrative
Code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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
H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Since it is unknown which device is directly implicated in this complaint, pxl161407 / sn# (b)(6) / udi: (b)(4) will be included on this report to the fda.
Additional Manufacturer Narrative
H6: code c19: a review of the manufacturing records indicated the lot met all pre-release specifications.Since it is unknown which device is directly implicated in this complaint: (b)(4)/sn# (b)(6)/udi-di: (b)(4) will be included on this report to the fda.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) states, adverse events that may occur and/or require intervention include: aneurysm enlargement and reintervention.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16769992
• Report Number: 3013164176-2023-01664
• Device Sequence Number: 19646430
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/03/2023

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: 07/31/2016
• Device Model Number: PLC271400
• Device Catalogue Number: PLC271400
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 05/03/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/19/2023; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 104 KG