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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on the information received from patient tracking department, a carbomedics top hat mechanical heart valve s5-019 that was implanted on (b)(6) 2019, was eventually explanted on (b)(6) 2023.No further information is 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, vercelli 13040 ; IT 13040
• MDR Report Key: 19055687
• Report Number: 3019892983-2024-01003
• Device Sequence Number: 7339154
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)210516
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2024
• Report Date (Section F): 03/07/2024

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: 05/16/2021
• Device Model Number: CPHV
• Device Catalogue Number: S5-019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2024
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• 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: 47 YR
• Patient Sex: Unknown