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

Model Number	T505C221
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a valve performance issue/dysfunction occurred with the 21mm hancock ii aortic valve, which is implanted and remains in service.The specific issues included valve stenosis and moderate regurgitation.The patient is being evaluated for a transcatheter valve-in-valve replacement.It was also noted that there was calcification observed in the left ventricular outflow tract (lvot) under the left coronary cusp (lcc) and right coronary cusp (rcc) and in the proximal right coronary artery and left coronary artery and in the sinotubular junction (stj).

• 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: 20877474
• Report Number: 2025587-2024-07131
• Device Sequence Number: 8928464
• Product Code: DYE
• UDI-Device Identifier: 00613994760531
• UDI-Public: 00613994760531
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2013
• Device Model Number: T505C221
• Device Catalogue Number: T505C221
• 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: 11/29/2024
• Initial Report FDA Received Date: 12/09/2024
• Date Device Manufactured: 09/22/2010
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 21 KG