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

Model Number	310C27
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Atrial Flutter (1730); Bradycardia (1751); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Dizziness (2194); Syncope/Fainting (4411); Insufficient Information (4580)
Date of Event	12/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 9 months post implant of this 27mm mitral bioprosthetic valve, a permanent pacemaker was implanted.The reason for the permanent pacemaker was reported as sinus node dysfunction, atrial arrhythmias and asystole.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.
Event or Problem Description
Medtronic received additional information which stated that an electrocardiogram (ecg) had revealed bradycardia of unclear etiology.It was stated that the patient had a syncopal episode and had been experiencing lightheadedness.A beta blocker medication was stopped.It was also reported that the patient had atrial fibrillation (afib) and atrial flutter and was taking an anticoagulant medication.Sick sinus syndrome (sss) was also reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated b5 updated b7 updated h6 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: MOSAIC 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: 20495801
• Report Number: 2025587-2024-05866
• Device Sequence Number: 3519400
• Product Code: DYE
• UDI-Device Identifier: 00643169594845
• UDI-Public: 00643169594845
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• 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,Followup
• Report Date (Section B): 11/07/2024

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 Expiration Date: 06/19/2021
• Device Model Number: 310C27
• Device Catalogue Number: 310C27
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 06/20/2016
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female