MAUDE Adverse Event Report: CORCYM CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number	CNA19
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer were informed about the crown prt valve-size 19 leakage and regurgitation.This valve was implanted on (b)(6) 2021, after the implant of the valve the regurgitation from the leaflet closure were found by echo.Based on the echocardiography results the ejection fraction was 34% (mod 4) with impaired systolic function in septal, anteroseptal and anterior wall akinesia due to the heart failure.Hemolysis and the hematuria was reposted for this patient but the relationship is unknown.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 13128978
• Report Number: 3019892983-2021-01061
• Device Sequence Number: 14551345
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)241231
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2021
• Report Date (Section F): 12/07/2021

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: 12/31/2024
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2021
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2021
• 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: 69 YR
• Patient Sex: Male