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

Model Number PVF-L

Device Problem Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-l , s/n # (b)(4), 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 (model pvf-l) perceval plus heart valve at the time of manufacture and release.Since the device was disposed at the hospital and was not returned to the manufacturer, further investigation cannot be performed.Since the device was discarded at the hospital, no inspection on the device can be performed.Based on the medical judgement received, the root cause of the event was attributed to the patient anatomy (i.E.''perhaps the exaggerated scallop of the non coronary cusp may have led to the incorrect positioning or movement of the perceval resulting in the paravalvular leak''), with no device malfunction being identified (i.E.''perceval valve itself looked fine'').Furthermore, from the document review performed, no manufacturing deficiencies were identified.Device was discarded at the hospital.

Event Description

On (b)(6) 2022, patient had an aortic valve replacement performed with a large size perceval plus valve.The patient was brought back to or the following day (monday, (b)(6)) as the valve was found to be rocking in position and had a significant perivalvular leak around the portion of the valve that sat against the non-coronary cusp.As reported, the leak was difficult to see and could only be pictured in one view.Patient's chest was reopened, and patient was put on pump with no issues.Upon opening the aorta and inspecting the valve, it could be seen that the posterior portion of the valve was sitting above the annulus, confirming the pre-op and intra-op echos.The valve was removed without any issue and inspected and it was commented that the perceval valve itself looked fine.Some additional debridement of the annulus was performed, and the annulus was sized for a crown, size 25.The crown was implanted intra-annular without incident.Surgeons mentioned that the patient's aortic valve cusps were very scalloped, more than usual, and most dramatically on the non-coronary cusp which could have been part of the cause for the issue.Based on the additional information received, there was some lv distension when coming off pump in the initial procedure, but during the second operation it was commented that in the first procedure, after closing the aorta, cardioplegia was given in the aortic root prior to taking the cross clamp off and the aortic root showed good pressure, meaning that the perceval plus valve should not have been leaking at that time.Based on the post-op echo report, the lvot area was 3.2 cm squared.As reported, there was no positioning issue noted in either the original perceval plus implant or subsistent crown implant.Based on the medical judgment received, it was thought that perhaps the exaggerated scallop of the non-coronary cusp may have led to the incorrect positioning or movement of the perceval, resulting in the paravalvular leak.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 14598876
• MDR Text Key: 293339069
• Report Number: 3004478276-2022-00154
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)260109
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150011
• 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
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2022
• 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 Sex: Male