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

Model Number PVF-M

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2022

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 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 as defined by the principal device function test at the time of release.A follow up report will be provided upon receipt of the additional information or device.

Event Description

The manufacturer was informed that pvf-m was implanted on (b)(6) 2022.When the cpb was finished, it was realized that one of the leaflets did not have motion.As such, the valve was explanted and another prothesis was implanted during the same day.

Manufacturer Narrative

The manufacturer was informed that no further information is available at this time.The valve was returned to the manufacturer.The visual inspection, performed on the returned prosthesis valve, did not highlight pre-existing defects.The hydrodynamic testing on the pvf-m was conducted.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of about 100 mmhg is 2.31 cm2, well above the iso 5840 minimum requirement 1.25 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 5.7 % and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions (see attached pictures).Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.The reported event cannot be explained by any factor intrinsic in the involved device because the claimed issues were not observed during the investigation carried out (i.E.Hydrodynamic test).As such, the definitive root cause of the event cannot be established.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: 15727486
• MDR Text Key: 303059545
• Report Number: 3004478276-2022-00207
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)260203
• 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
• Report Date: 01/03/2023

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: 10/04/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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