MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number	310C31
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Hemothorax (1896)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 16 years post implant of this 30mm mitral annuloplasty ring, it was explanted and replaced with a 31mm bioprosthetic valve.The reason for the replacement was not reported.No additional adverse patient effects were reported.Additional information was received which stated that the reason for replacement was recurrent severe symptomatic mitral regurgitation (mr) and mildly reduced ejection fraction (ef).It was reported that the patient required three defibrillations and two units of platelets following replacement of the ring.It was further reported that there was ongoing bleeding with a retained hemothorax post procedure on the same day.It was noted that during the mitral valve replacement procedure that day that the patient had extensive pulmonary adhesiolysis.It was stated that there was two bleeding sites from the apex of lung and chest from adhesiolysis.A reopening of the recent thoracotomy, evacuation of the retained hemothorax and washout of pleural spaces was performed.It was stated that a significant amount of retained clot was evacuated from the right pleural space.It was noted that pledgeted repair of pulmonary bleeding at the apex of lung and cautery hemostasis of the chest wall in two locations was also performed during this procedure.Anintra-operative echocardiogram showed that the mitral valve was well seated and still working well.It was also indicated that a permanent pacemaker was subsequently implanted in the patient.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: MOSAIC MITRAL 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: 19229508
• Report Number: 2025587-2024-02724
• Device Sequence Number: 17865464
• Product Code: DYE
• UDI-Device Identifier: 00643169001596
• UDI-Public: 00643169001596
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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 Model Number: 310C31
• Device Catalogue Number: 310C31
• 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: 04/04/2024
• Initial Report FDA Received Date: 05/02/2024
• Date Device Manufactured: 12/04/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male