MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through the patient tracking department.Based on the information received, a carbomedics mechanical standard heart valve m7-029 was implanted in the patient on (b)(6) 2022.Based on the information on patient's implant form, on (b)(6) 2022, a similar device m7-029 was implanted in the patient.The manufacturer has not received any allegation of device malfunction nor of serious injury on the patient from the site regarding this event.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 15106052
• Report Number: 3019892983-2022-01041
• Device Sequence Number: 4116573
• Product Code: LWQ
• UDI-Device Identifier: 08022057012739
• UDI-Public: (01)08022057012739(240)M7-029(17)240229
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2022
• Report Date (Section F): 06/29/2022

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: 02/29/2024
• Device Model Number: CPHV
• Device Catalogue Number: M7-029
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2022
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male