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

Model Number PVS23

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/08/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs23 implant attempt occurred.After the implant the leaflets appeared stiff.The valve was explanted and replaced with a perimount valve size 21.Based on additional information provided, the valve collapsing and preparation was performed as usual, no anomalies were detected.The valve positioning in the dual collapser occurred with no problem and the valve was collapsed normally.The valve was stored in saline solution prior to the implant.After the valve implant and declamp, the echo showed that the valve leaflets were "frozen" (i.E.Blocked in the open position).The valve was not closing and the echo findings showed a massive aortic insufficiency.The valve appeared well positioned.The bypass was restarted and the valve inspected.The leaflets appeared not to close properly and were immobile.No cusp tears were identified, but the leaflets appeared thickened.There was no adverse event for the patient who was already discharged after finally implanting perimount valve 21 instead.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12595482
• MDR Text Key: 278143713
• Report Number: 3019892983-2021-01018
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)240403
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021,10/07/2021

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 Expiration Date: 04/03/2024
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/08/2021
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention