MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number	T505C223
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Atrial Flutter (1730); Chest Pain (1776); Endocarditis (1834); Obstruction/Occlusion (2422); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 7 years and 9 months post implant of this 23mm aortic bioprosthetic valve, it was reported that the patient was admitted to the hospital for endocarditis infection.The organism cultured was e.Faecalis.The patient was administered antibiotics.Subsequently, 4 days later, the patient returned to the emergency department (ed) with monocular left eye vision, a new occlusion of left internal carotid artery (ica), and evidence of atrial flutter.Medication was administered.Then, 2 months later, the patient as admitted to the ed for chest pain.A computerized tomography (ct) scan discovered prolapse or flail of the right coronary cusp of the aortic valve, which also led to severe aortic regurgitation and aortic stenosis.Subsequently, on december 26, 2025, the patient successfully had an aortic valve-in-valve replacement with a transcatheter valve.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24132321
• Report Number: 2025587-2026-00080
• Device Sequence Number: 21432652
• Product Code: DYE
• UDI-Device Identifier: 00643169594302
• UDI-Public: (01)00643169594302(17)200120
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2020
• Device Model Number: T505C223
• Device Catalogue Number: T505C223
• 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: 12/23/2025
• Initial Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 01/20/2017
• 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; Required Intervention; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Male