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

Model Number CNA19

Device Problems Degraded (1153); Biocompatibility (2886)

Patient Problems Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 07/07/2023

Event Type  Injury  

Event Description

The manufacturer was informed that a crown valve size 19 which was implanted in 2021 was explanted on (b)(6) 2023 since the functionality (open and close) of the valve was getting worse due to pannus.Reportedly, the valve was replaced with a mechanical valve regent 17mm and surgery went well without problem.

Manufacturer Narrative

H3 other text : discarded by site.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.Corrected fields: h6.Since serial number of the device was not available and the device was not returned to the manufacturer, further investigation on the device cannot be performed.Since further investigation on the device could not be performed, the definitive root cause of the reported event cannot be established at this time.It is possible that patient condition and clinical risk factors may have contributed to this event but since limited information is available this cannot be ultimately confirmed.Should further information be received in the future, a follow up report will be provided.

Event Description

The manufacturer was informed that a crown valve size 19 which was implanted in 2021 was explanted on (b)(6) 2023 since the functionality (open and close) of the valve was getting worse due to pannus.Reportedly, the valve was replaced with a mechanical valve regent 17mm and surgery went well without problem.Based on the further information received, there was no impact on the patient and outcome was good.The manufacturer was informed that no further information will be provided.

• 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17464521
• MDR Text Key: 320447088
• Report Number: 3004478276-2023-00169
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• 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
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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