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

Model Number CNA19

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/10/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 285671121
• Report Number: 3019892983-2021-01061
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)241231
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2021,12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male