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

Model Number	PLC181200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event also includes device (b)(4).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
On (b)(6) 2023, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and two gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2023, the patient presented with a suspected type ib endoleak from the contralateral leg limb in the left common iliac.The physican extended the limb with two additional gore® excluder® aaa endoprostheses distally to the origin of the left hypogastric.The physician also used a medtronic balloon to balloon the devices on the left side, as well as the right common iliac, as there was a possible type ib endoleak on the right limb extension off the main body.The procedure was successful, and the endoleaks were resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak.H.6.Type of investigation code b21 updated to code b14 with completion of phr review.H.6.Investigation findings: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.
Additional Manufacturer Narrative
G1 - manufacturing site - corrected site to silicon valley manufacturing site.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16964677
• Report Number: 2017233-2023-03944
• Device Sequence Number: 5392467
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 11/13/2025
• Device Model Number: PLC181200
• Device Catalogue Number: PLC181200
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023; 05/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 05/24/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male