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

Catalog Number	PLC161400
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	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular treatment of a prior endovascular repair with a medtronic afix graft and a vela cuff.Gore® excluder®aaa endoprosthesis were implanted to treat a proximal type i endoleak due to suspected migration of the medtronic devices.Pre-treatment maximum aortic diameter measured 52mm.On (b)(6) 2024, the site reported the patient had a type iii endoleak.On (b)(6) 2024, the patient underwent other treatment or procedure for the type iii endoleak.The patient tolerated the procedure.Additional details have been requested.
Additional Manufacturer Narrative
Additional devices that may be associated with this event include: rlt231412/13890164, (udi) (b)(4) pla230300/14017446, (udi) (b)(4).Patient medical history includes but is not limited to: hypertension, peripheral vascular disease.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.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: 19525229
• Report Number: 3013164176-2024-02099
• Device Sequence Number: 15355049
• Product Code: MIH
• UDI-Device Identifier: 00733132618729
• UDI-Public: 00733132618729
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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 Catalogue Number: PLC161400
• 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: 05/31/2024
• Initial Report FDA Received Date: 06/12/2024
• Date Device Manufactured: 12/05/2023
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 136 KG