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	Aortic Valve Stenosis (1717)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through patient tracking.The top hat supranuclear valve size 19, which was implanted on (b)(6) 2013, was explanted on (b)(6) 2020 due to severe aortic stenosis and valvular disease.The st.Jude 21mm valve was implanted in the patient instead.No further information is presently available.

• 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: 13772158
• Report Number: 3019892983-2022-01019
• Device Sequence Number: 3967162
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)151219
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022
• Report Date (Section F): 02/17/2022

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: 12/19/2015
• 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: 02/17/2022
• Device Age: 114 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2022
• 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: Other
• Patient Age: 47 YR
• Patient Sex: Female