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

Catalog Number	PLC141200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2019, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.It was reported that images (modality and date is unknown), revealed ¿suspected bilateral iliac artery stenosis/graft compression inside treated area¿.An angiogram and evaluation for treatment of possible bilateral iliac stenosis/graft compression will occur on january 04, 2024, with maggie lin, md.Event is ongoing at this time.
Additional Manufacturer Narrative
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
An angiogram and evaluation for treatment of possible bilateral iliac stenosis/graft compression will occur on (b)(6) 2024, with maggie lin, md.Reportedly on (b)(6) 2024, after angiogram there was a reintervention.The left side was found to have a stenosis distal to the contralateral limb and was treated with an 8l x 39mm vbx balloon expendable endoprosthesis (l/s#: (b)(6)) followed by a 14mm x 4cm xxl balloon (boston scientific), the stenosis was treated successfully, and the patient tolerated the procedure fine.During the same procedure, the physician chose to access the right side (main body limb) to identify if there was any narrowing evident on the side.It was determined that there was not full wall apposition in the most distal part of the limb and that area was then treated with a 12mm x 2cm charger balloon (boston scientific).The wall apposition was achieved with this ballooning and the physician decided to that no further intervention on that side was necessary.The patient tolerated the procedure and is reported to be doing fine.
Additional Manufacturer Narrative
The gore® excluder® aaa endoprosthesis instructions for use (ifu) states: patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.
Additional Manufacturer Narrative
Review of the event determined this event/device to be non-reportable.This medwatch will be voided/retracted.(b)(4) is a non-complaint, the stenosis was identified distal to the plc and was treated accordingly.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18528240
• Report Number: 3013164176-2024-01962
• Device Sequence Number: 7596918
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: 00733132618675
• 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: 2019
• 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): 02/27/2024

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: 05/21/2022
• Device Catalogue Number: PLC141200
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 12/20/2023
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/16/2024; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 84 KG