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

Model Number	PLC121000
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Foreign Body Embolism (4439)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent endovascular procedure to treat an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the right internal iliac artery was unintentionally covered.Reportedly, the physician felt that the device was landed safely above the internal iliac artery (iia) ostium.However, the final angiogram determined that the right internal iliac artery was occluded.The physician believes that the cause of the unintentionally coverage of the right internal iliac artery was due to the short common iliac artery, small/stenosed origin of the internal iliac artery higher than viewed on intraoperative image.The physician felt they marked the rt iia ostium accurately and landed conservatively.They only found the rtiia occluded on final angiogram.At the time of reporting, the patient was doing well.It was reported that the case was occurred without gore fsa support.It was not able to get the information from the physician if the vessel occlusion was solved or is monitoring.No more information is available.
Additional Manufacturer Narrative
H6: code c19: a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.The device remains implanted and is not available for analysis.The physician believes that the cause of the unintentionally coverage of the right internal iliac artery was due to the short common iliac artery, small/stenosed origin of the internal iliac artery.It was not able to get the information from the physician if the vessel occlusion was solved or is monitoring.Additional information was requested but was not available.The gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy: iliac artery treatment diameter range of 8-25 mm and iliac distal vessel seal zone length of at least 10 mm.Key anatomic elements that may affect successful exclusion of the aneurysm include distal iliac artery interface.Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Do not cover significant arteries with the endoprosthesis.Vessel occlusion may occur.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to occlusion of device or native vessel.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.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16957452
• Report Number: 3013164176-2023-01695
• Device Sequence Number: 3466269
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: 00733132618613
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/18/2023

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: 01/23/2026
• Device Model Number: PLC121000
• Device Catalogue Number: PLC121000
• 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: 05/11/2023
• Initial Report FDA Received Date: 05/18/2023
• Date Device Manufactured: 01/25/2023
• 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: Other; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female