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

Model Number PVF-M

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve, model #pvf-m, 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-m perceval plus heart valve at the time of manufacture and release.The steady flow test review was also performed.The images demonstrate the acceptable opened and closed leaflet performance of the perceval pvf-m sn# (b)(4).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in dedicated procedure, the principal device function test at the time of release.

Event Description

The manufacturer was informed that perceval plus sutureless aortic heart valve, pvf-m was implanted through right lateral anterior mini-thoracotomy on (b)(6) 2022.After the cpb, in the control echo, a mild central leak was observed.Reportedly, the pump time was 55'.In the echo 12 hours after implantation, a moderate/severe central leak as well as a paravalvular leak was observed.As such, the valve was explanted on (b)(6) 2022 and an edwards carpentier size 21 was implanted instead in supraannular position.

Manufacturer Narrative

The device was received by manufacturer on 15 sep 2022.A follow up report will be provided upon completion on device investigation.

Manufacturer Narrative

The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing macroscopic abnormalities and/or pre-existing defects according to specifications.The valve was stained with blood and the pericardium has an onset of dehydration, particularly evident on the edge of the free margin of the leaflets.The storage conditions before returning the product were probably not optimal: the free margins show the typical appearance and morphology due to a dehydration process that has altered the mechanical properties of the pericardium.For this reason, any further investigation (i.E.Hydrodynamic test) was considered not representative of the original conditions.As such, no further investigation could be performed.Based on the analysis performed, no pre-existing defects with the valve were identified.Review of the manufacturing data for the returned valve also confirmed that the valve satisfied all material, dimensional, and performance standards required for pvf-m at the time of manufacture and release.Based on the information available, edwards carpentier valve size 21 was ultimately implanted in the supra-annular position.Comparing the internal diameter indicated in the sizing table for edwards carpentier size 21 and aortic diameter for perceval plus size m, points at an oversizing as a possible root cause of the reported event.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC 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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15397511
• MDR Text Key: 299665627
• Report Number: 3004478276-2022-00184
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)260416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• 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: 11/11/2022

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: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/10/2022
• Supplement Dates Manufacturer Received: 09/15/2022; 10/14/2022
• Supplement Dates FDA Received: 10/11/2022; 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2022
• 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