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 02/17/2023

Event Type  Injury  

Event Description

The manufacturer was informed of the following event through patient tracking department.Reportedly, a carbomedics top hat aortic heart valve size 21 was implanted and explanted intra-operatively on (b)(6) 2023.No allegation of a device malfunction nor serious injury was received from the site regarding this event.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, vc 13040 ; IT 13040
• MDR Report Key: 17931855
• MDR Text Key: 325624899
• Report Number: 3019892983-2023-01016
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)251113
• 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: 09/13/2023,10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2023
• Date Manufacturer Received: 09/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR