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

Model Number PVS21

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a perceval valve size 21 was attempted to be implanted in a patient.Reportedly after de-clamped, the valve did not work well as leaflet did not open.As such, the valve was explanted and replaced with epic (unknown size).No further information is available at this time.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacture¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model #icv1208) perceval heart valve at the time of manufacture and release.Steady flow test review was also performed.The images demonstrate the acceptable opened and closed leaflet performance of the perceval pvs21 sn# (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in the dedicated procedure at the time of manufacture and release.A follow up report will be provided upon completion of the investigation on the device and/or receipt of any further information.

Manufacturer Narrative

The device has been returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications except a deformation on the leaflet #3 that appeared a little tensioned at the base of it.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg is 2.37 cm2, above the iso 5840 minimum requirement 1.05 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 4.2% and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.Anomaly was observed during the valve diastolic phase under hypotensive conditions: a slight central leakage was detected while no anomaly was observed under normotensive conditions.Otherwise, no anomalies were observed during valve opening, except to valve fluttering under normotensive condition on leaflet #3.From the analysis and comparison of the images of the valve in the opening configuration of functional test and steady flow test, it can be seen how, the leaflets have a reduced opening in the function test compared to the pictures of the valve at the time of manufacturing release (steady flow test).Although the valve opening is to be considered within the specification values (according to the iso limits), it is also true that what was found during the test is to be considered reasonably in line with what was claimed by the customer.It is worth underlining that the behavior of the valve is slightly different compared to what was documented during the release test: the morphology of the free edge of leaflet #3 in the closed position is clearly recognizable, but the morphology during the opening phase is very different, showing an unnatural deformation which is difficult to establish if it is associated with a pre-existing defect since it was not present during the release test.Therefore, it is not possible to completely exclude that this is caused by manipulations during the implantation phase which occurred inadvertently.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because: despite the slight anomaly observed during the open phase of functional test, the returned prosthesis meets the iso 5840:2021 minimum requirements furthermore, review of the data filed in the device history record of the returned perceval heart valve sn (b)(6), confirmed that the valve satisfied all material, dimensional, and performance standards required for a perceval valve pvs 21/s at the time of manufacture and release, including a visual inspection and a steady flow test.It cannot be totally excluded that a small anomaly observed during the opening phase is due to a deformation which occurred after the deployment of the valve since the same behavior was not detectable in the steady flow test performed at manufacturing release, but this cannot ultimately be confirmed.

Event Description

On 20 oct 2023, a perceval valve size 21 was attempted to be implanted in a patient.Reportedly after de-clamped, the valve did not work well as leaflet did not open.As such, the valve was explanted and replaced with epic size 21mm.Based on the further information received, there was no impact on the patient and outcome was good.20 minutes added to the procedure as a result of this event and patient remained stable through the procedure.No malfunction noted with the device.Reportedly, there was no abnormal geometries in the patient anatomy.No further information is available.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18165410
• MDR Text Key: 328966824
• Report Number: 3004478276-2023-00200
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)260208
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 02/08/2024

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: PVS21
• Device Catalogue Number: ICV1208
• 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: 10/20/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 01/12/2024
• Supplement Dates FDA Received: 12/29/2023; 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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 Age: 69 YR
• Patient Sex: Female