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

Model Number S5-023

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Received the following information through the patient tracking department.On (b)(6)2022, a patient received a carbomedics top hat valve s5-023.As reported, the patient passed away at a later date (exact date and cause unknown).No other details about the patient, event or allegation of any device dysfunction have yet been received from the site.Manufacturer was informed that no further information can be provided.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 18422352
• MDR Text Key: 331664612
• Report Number: 3019892983-2023-01026
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)261221
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023,12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S5-023
• 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: 12/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2023
• Date Manufacturer Received: 12/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death