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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2023

Event Type  Injury  

Event 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
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 19055687
• MDR Text Key: 339554051
• Report Number: 3019892983-2024-01003
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)210516
• 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: 03/07/2024,04/05/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR