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

Catalog Number	PLL161407
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, this patient underwent endovascular treatment of a zone 9 abdominal aortic aneurysm and was implanted with gore® exclude® conformable aaa endoprostheses, (cxt231412/27655726) the right-side contralateral gate was cannulated and implanted with a contralateral leg endoprosthesis (plc141400/26957820).Additionally, the right internal iliac artery (riia) was coil embolized and an iliac extender endoprosthesis (pll161407/24050302) was implanted to extend coverage down with intentional coverage of the riia.The patient tolerated the procedure with good results.On (b)(6) 2024, the patient underwent endovascular reintervention for treatment of distal type i endoleaks on the right side.The physician reported distal type i endoleaks outside the distal end of both the contralateral leg and the extension device (not between them outside them).A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted to reline and extend coverage in the common iliac artery.The type i endoleaks were resolved, but in the process of putting a stiff wire up the contralateral limb, the plc141400 became separated from the contralateral gate of the device of the main body, creating a type iii endoleak.An additional plc141400 was advanced and implanted to bridge the gap and resolve the type iii.The patient tolerated the procedure.
Additional Manufacturer Narrative
Patient medications include but are not limited to: xopenex hfa aerosol with adapter, eliquis, norvasc, voltaren, vitamin b&d fish oil, potassium chloride patient medical history includes but is not limited to: history of supraventricular tachycardia hypertension hyperlipidemia copd history of aaa coronary artery disease peripheral vascular disease, tobacco the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states; adverse events that may occur and / or require intervention include but are not limited to: endoleak 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19580132
• Report Number: 3013164176-2024-02110
• Device Sequence Number: 20680555
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: 00733132618767
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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
• Device Expiration Date: 08/15/2024
• Device Catalogue Number: PLL161407
• 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: 06/11/2024
• Initial Report FDA Received Date: 06/21/2024
• Date Device Manufactured: 08/17/2021
• 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; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 78 KG