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

Model Number CNA19

Device Problems Leak/Splash (1354); Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

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 reported for this patient.

Manufacturer Narrative

The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, s/n # (b)(6) , as they pertain to the reported event, 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.The manufacturer attempted to retrieve additional information on the event and treatment plan for the patient, but no further information was provided.Since the device remains implanted (no notification of valve explant was provided), no further investigation is possible at this time.Based on the available information, it is not possible to make a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficiencies were identified.The manufacturer attempted to follow up with the field, but no further information was received up to date.Should any further information be received, the manufacturer will provide a supplemental report as applicable.

Manufacturer Narrative

Fields updated: b4, b5, g3, g6, h2, h6.The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, s/n # (b)(6), as they pertain to the reported event, 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.Based on the available information, it is not possible to make a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficiencies were identified.As reported, no surgical re-intervention was performed and no more complication for the patient has been occurred.Thus, there is not enough evidence to suspect a definitive device malfunction as the device remains implanted in the patient.Thus, no further investigation is deemed warranted at this time.Should any further information be received in the future, the manufacturer will provide a supplemental report as applicable.

Event Description

The manufacturer were informed about the crown prt valve-size 19 leakage and regurgitation.This valve was implanted on 10 nov 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 were reported for this patient.Based on the new information received no surgical intervention were performed and no more complications has been reported from the field.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• 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: 13129066
• MDR Text Key: 284978169
• Report Number: 3004478276-2021-00297
• 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: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

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
• 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
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: 02/07/2022; 02/11/2022
• Supplement Dates FDA Received: 02/10/2022; 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male