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

Model Number PVS23

Device Problems Collapse (1099); Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/04/2023

Event Type  Injury  

Event Description

The manufacturer was informed that a perceval valve pvs size 23 implanted on (b)(6) 2023 was explanted in the following weeks due to perivalvular leak, detected by the surgeon at an echo check.The prosthesis was replaced with a conventional valve.As reported by the surgeon, it appeared that two of the pvs valves' leaflets did not return to the original position.It was also reported that patient's native valve was bicuspid type i.No further information is available at this stage.

Manufacturer Narrative

The manufacturer is following up with the site on the event and the device involved and will submit a follow up report upon receipt of further information or availability of investigation results.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and stent, model # icv1209, s/n # (b)(6) , as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1209 perceval heart valve at the time of manufacture and release.The explanted device was returned to the manufacturer for analysis and was received in a plastic jar for specimen filled with an unknown liquid and unusual presence of foam.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications but with signs of alteration, including one the leaflets appearing deformed.The leaflets appeared stiff and showed difficulty in moving as if the valve had been kept in an incorrect storage liquid that had altered the pliable properties of the leaflets.On the other hand, this appearance could have also been a consequence of morphological alterations caused by the non correct functioning conditions occurred during the period the prosthesis remained implanted.Signs of deformations were also detected in correspondence with the sealing collar in the area near one of the posts in contiguity with the deformed leaflet (post #1).In order to allow an exhaustive evaluation of the functional behaviour, a hydrodynamic testing in simulated physiological conditions was performed on the returned prosthesis.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean aortic pressure of about 100 mmhg was 2.09 cm2, above the iso 5840 minimum requirement of 1.25 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction was 6.2%, which is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.Despite the altered morphological conditions of the returned prosthesis, no anomalies were observed during the open/close cycle under normotensive conditions, while under hypotensive conditions a partial valve opening was observed, with one of the leaflets which remained stuck, and an incomplete coaptation involving the deformed leaflet was noticed which caused a not negligible valve leakage.The images, resulting from the hydrodynamic test carried out and those recovered from the manufacturing records related to the steady flow test performed before the valve release, were analysed and compared.From the analysis and comparison of the images in the open configuration, it was evident that at the testing performed on the returned prosthesis the leaflets showed a reduced opening compared to what documented at the time of valve release.This may be a reasonable evidence that the mechanical characteristics (elasticity and flexibility) of the pericardium have been impaired to some extent.It follows that the tests, carried out in our laboratories, can only be partially considered representative, of the behavior of the prosthesis while implanted.A simulation of collapsing, deployment and ballooning phases according to the indications included in the ifus was also performed, using the returned valve pvs 23/m and a demo accessory kit.In particular, a silicon aortic root, size 23 was used to simulate valve deployment and ballooning.Then, in order to mimic the anatomical conditions, the silicon aortic root was reinforced at the annulus level by means of an o-ring.Finally, a static leak test was performed.No issues were encountered in the collapsing phase, and the replication was completed with a satisfactory result despite some overlapping of the stent structures that was seen in the outflow area and the pillar of post #1 which appeared slightly deformed.During the simulation of the valve deployment in silicon aortic root #23, no problems were encountered during the ballooning phase and the sealing at the annulus level was guaranteed, with the valve that remained fixed within the annulus.Then, inserting some water in the aortic root from the outflow side, no paravalvular leaks were observed during the simulation.Based on the information received and the analyses performed, the reported event cannot be explained by any factor intrinsic to the involved device.As reported, although patient's anulus was sized to be 20-21 mm intra-operatively, the decision to implant a perceval size m was taken.The root cause of the reported event can thus be identified in an oversizing of the perceval valve which led to stent folding ultimately resulting in the observed pvl and high gradients, as also confirmed by medical judgement received.

Event Description

The manufacturer was informed that a perceval valve pvs size 23, implanted for isolated avr through full sternotomy on (b)(6) 2023, was explanted and replaced with a conventional bioprosthesis from a different manufacturer (medtronic avalus size 21) on (b)(6) 2023 due to perivalvular leak and high gradients detected by the surgeon at an echo check.As reported, the patient's native valve was bicuspid type i and was apparently symmetrical with respect to commissural alignment, with three well-differentiated raphes and fusion of intercoronary leaflets.Based on the further information received, no collapsing issues nor difficulties in valve positioning had been encountered at the time of perceval valve implant.The intra-operative tee check, had shown a good functionality of the implanted prosthesis, which seemed well expanded, although the outflow tract was not visualized.Reportedly, at the time of initial surgery, the patient was in a very advanced functional class and evacuation of bilateral pleural effusion was performed in the same procedure.Initial patient's outcome was good, with an improvement in clinical conditions until prosthesis dysfunction was detected, with the valve showing an under-expansion in the annulus area as well as high gradients, leading to the decision to perform reintervention for perceval prosthesis replacement.Based on further information received, despite patient's annulus was sized 20-21 mm intra-operatively, size m was selected to try to achieve complete sealing.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.Conclusion will remain the same.

Event Description

The manufacturer was informed that a perceval valve pvs size 23, implanted for isolated avr through full sternotomy on (b)(6) 2023, was explanted and replaced with a conventional bioprosthesis from a different manufacturer (medtronic avalus size 21) on (b)(6) 2023 due to perivalvular leak and high gradients detected by the surgeon at an echo check.As reported, the patient's native valve was bicuspid type i and was apparently symmetrical with respect to commissural alignment, with three well-differentiated raphes and fusion of intercoronary leaflets.Based on the further information received, no collapsing issues nor difficulties in valve positioning had been encountered at the time of perceval valve implant.The intra-operative tee check, had shown a good functionality of the implanted prosthesis, which seemed well expanded, although the outflow tract was not visualized.Reportedly, at the time of initial surgery, the patient was in a very advanced functional class and evacuation of bilateral pleural effusion was performed in the same procedure.Initial patient's outcome was good, with an improvement in clinical conditions until prosthesis dysfunction was detected, with the valve showing a non correct expansion in the annulus area as well as high gradients, leading to the decision to perform reintervention for perceval prosthesis replacement.Based on further information received, despite patient's annulus was sized 20-21 mm intra-operatively, size m was selected to try to achieve complete sealing.Reportedly, ballon was inflated during the intervention.Patient is doing well, with a conventional valve.Patient's native valve was functional bicuspid and at first glance patient's native valve it did not look like a native bicuspid.

• 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: 17918388
• MDR Text Key: 325444832
• Report Number: 3004478276-2023-00183
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)260330
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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: Female