MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer became aware of the following event through patient tracking department.Reportedly, a carbomedics top hat s5-023 that was implanted and explanted intraoperatively on (b)(6) 2024.Based on the further information received, the device was explanted due to leakage/regurgitation and was replaced with a medtronic avalus bioprosthetic valve.No other details are available at this time.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino saluggia; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 19784708
• Report Number: 3019892983-2024-01011
• Device Sequence Number: 8428632
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)271114
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2024
• Report Date (Section F): 06/20/2024

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: CPHV
• Device Catalogue Number: S5-023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/20/2024
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female