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 10/11/2021

Event Type  Injury  

Event Description

The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a carbomedics top hat mechanical heart valve s5-025 was implanted on (b)(6) 2014.After more than 7 years, the device was explanted on (b)(6) 2021 and replaced with another carbomedics top hat mechanical heart valve s5-023.No further information about any device malfunction or patient outcome was received from the site regarding this event.

• 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: 13082138
• MDR Text Key: 284705542
• Report Number: 3019892983-2021-01055
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012920
• UDI-Public: (01)08022057012920(240)S5-025(17)170202
• 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: 11/24/2021,12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2017
• Device Model Number: CPHV
• Device Catalogue Number: S5-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2021
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Date Manufacturer Received: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male