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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a carbomedics top hat valve model s5-019 was intended for an aortic valve replacement (native valve) procedure.As confirmed, the device was tested with the dedicated tester and no fault was identified at that time.During unclamping, it was identified that the valve was stuck when opening, specifically, one leaflet did not open and did not allow flow.As such, the surgeon removed the device and tried to reposition it in the patient, first testing the valve with the dedicated testers.Then, the valve was removed, and a new carbomedics standard aortic valve was put in, which worked at the time of placement.As reported, the functionality of the top hat valve model s5-019 valve was approved, the failure was detected when unpinning and at this time it was realized that the valve leaflets did not open.There was no bad position, it was measured, tested and broken with the device's gauges and rotators correctly.

• 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: 12025763
• Report Number: 1718850-2021-01120
• Device Sequence Number: 4339575
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)25320
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 06/26/2025
• Device Model Number: CPHV
• Device Catalogue Number: S5-019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/20/2021
• Device Age: 13 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2021
• 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: 50 YR
• Patient Weight: 55