MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	T510C33
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Fever (1858); Thrombosis/Thrombus (4440); Tricuspid Valve Insufficiency/ Regurgitation (4453); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 7 years and 4 months post implant of this 33mm mitral bioprosthetic valve, it was explanted and replaced with a 33mm mitral bioprosthetic valve of the same model.The reason for the replacement was not reported.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.
Additional Manufacturer Narrative
Updated data: a.4: patient weight b.1: adv evnt/prod prob: b.2: outcome attributed to adverse event b.5: event description b.7: relevant history h.6: coding 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
Additional information was received that reported the reason for replacement as leaflet flail with severe tricuspid regurgitation.It was also reported that the patient presented to the emergency department with dyspnea, cough, and fever.A computed tomography angiography (cta) was performed and discovered occlusive thrombus in the right lower lobe.Medication was administered.No additional adverse patient effects were reported.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 20664598
• Report Number: 2025587-2024-06469
• Device Sequence Number: 17984966
• Product Code: LWR
• UDI-Device Identifier: 00643169027138
• UDI-Public: 00643169027138
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 10/23/2017
• Device Model Number: T510C33
• Device Catalogue Number: T510C33
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 10/24/2014
• 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; Life Threatening; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG