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

Model Number	CNA19
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 a crown prt valve was implanted and explanted on the same day due to the regurgitation.Based on the report written by the surgeon, post implantation of the valve, one of the valve leaflet tissue appeared a bit tougher than the other two leaflets.After the valve replacement and coming off of cardiopulmonary bypass, the tee on table showed a central jet moderate to sever aortic prosthesis regurgitation and coaptation failure.Surgeon re-opened the aorta and found that ncc leaflet was stretched by the two commissures and it was not coapting at the same level as the other two.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19 were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.A review of the function test (open/close valve) at the time of manufacture and release was also performed.The video playback showed synchronous opening and closing of the valve with smooth, continuous motion and no leaflet fluttering.Based on video playback and review for this report, the valve performed as expected and met applicable function test quality control criteria for model cna19.
Additional Manufacturer Narrative
As confirmed with the hospital, the device will not be returned to the manufacturer for further investigation.Since the device was not returned to the manufacturer, further investigation on the device can not be performed and definite root cause of this event can not be established.However, the review of the manufacturing and material records performed showed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.Should any further information be received in the future, the manufacturer will provide a supplemental report as applicable.H3 other text : as per confirmed with the hospital the device will not be returned to the manufacturer for further investigation.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13231589
• Report Number: 3004478276-2022-00113
• Device Sequence Number: 4409210
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)230131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: 01/31/2023
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/14/2022; 03/16/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/10/2022; 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown