MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVES

Model Number TBD

Device Problem Insufficient Information (3190)

Patient Problem Thrombocytopenia (4431)

Event Type  Injury  

Manufacturer Narrative

The manufacturer is confirming the exact number of devices involved in the event.If applicable a separate medwatch will be submitted should further devices being identified.No evidence of device being explanted.

Event Description

The manufacturer was informed of a thrombocytopenia event after the implantation of the perceval valve.According to the information available, the platelet counts dropped to 30k in 2 cases.There is no further information available at this time.

Manufacturer Narrative

Fields updated: b4, g3, g6, h2, h3, h6 since no information is available regarding the device disposition and the serial number, further investigation is not possible.Based on the limited information available, it is not possible to establish a definitive root cause of this event.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.The manufacturer attempted to follow up with the field but no further information was received.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity as applicable.H3 other text : no evidence of device being explanted.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: 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: 13213189
• MDR Text Key: 285353972
• Report Number: 3004478276-2022-00112
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Report Date: 03/11/2022

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: TBD
• Device Catalogue Number: TBD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 03/12/2022
• 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): Other