MAUDE Adverse Event Report: CORCYM CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number CNA19

Device Problems Degraded (1153); Material Deformation (2976)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

The manufacturer was informed that a crown cna 19 valve was implanted in a patient about 4 months ago in (b)(6) 2023.Since svd and pvl were noted, the valve is planned to be explanted in (b)(6) 2023.Reportedly, the details will be provided after re-operation.No further information is available at this time.

Manufacturer Narrative

The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at corcym canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.Function test review was also performed.Video showed synchronous opening and closing with smooth, continuous motion and no leaflet fluttering.Meets all function test criteria observable on video for a size 19 model cn.Based on video playback and review for this report, the above valve performed as expected and met applicable function test quality control criteria as per dedicated procedure at the time of manufacture and release.The explanted valve has been returned to the manufacturer and was received in general acceptable storage conditions.The pericardium appeared slight stiff (apparently as per incoming dehydration) but still soft enough to have a quite good leaflet mobility.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications, apart from a deformation noticed at the preliminary inspection.One leaflet appeared with the free edge below the correct coaptation line.A hydrodynamic test was conducted on the returned cna19.The effective orifice area (eoa) at 70 bpm, c.O.Of 5.0 l/min and m.A.P.Of 100 mmhg is 1.10 cm2, which is above the iso 5840 minimum requirement of 0.85 cm2; the regurgitant fraction (rf%), under the same testing conditions, is 5.0%, which is below the iso 5840 requirement of 10% for a prosthesis of equivalent size.No anomalies were observed during the open/close cycle under normotensive conditions while, under hypotensive conditions, a not complete valve opening was detected.In general, as regards the complete coaptation of the leaflets and therefore the possible regurgitation, no anomalies were observed in both normotensive and hypotensive conditions.Considering the state of the device returned (4 months after the implant), and the deformation detected, it is possible to consider that the behavior of the valve is still acceptable.After the stent removal from the pericardium and dacron, a dimensional and geometrical analysis, was performed by means of optical instrument, which confirmed a deformation in terms of: circularity: more than 0.5 mm of difference between the maximum and minimum diameter.Deflection of the posts with respect to the principal symmetrical axis: about 2.5° in the post 1, no deflection in the post 2, and almost 5° in the post iii.The deformation of the stent is confirmed by an evident eccentricity of the circularity (difference between max-min diameter greater than 0.5 mm) and a visible deflection angle with respect to the verticality of the cylindrical shape of the three posts.The measured deformation seems to be reduced with respect to the geometry observed on the prosthesis as received.It is therefore possible to conclude that the regurgitation observed was possibly due to the deformation mentioned above, which was caused by the stress induced during implantation.Based on the performed analysis, the claimed issue was not confirmed by the investigation carried out (i.E.Hydrodynamic test) which results were in compliance with the standard of en iso 5840:2021.A significant deformation (reasonably occurred at the implant) was observed which can be reasonably considered the root cause of the reported event, in alignment with the medical judgement received.

Event Description

The manufacturer was informed that a crown cna19 tissue valve, size 19, was implanted in a patient about 4 months ago in (b)(6) 2023.No information regarding medical history and medications were reported to the manufacturer.Reportedly, since svd and pvl were noted, the valve was explanted on (b)(6) 2023 and replaced with a perceval s pvs23, size m sutureless aortic bioprosthesis.No details on surgical approach are available to the manufacturer.It was reported that.During the re-intervention, after the prostetic valve extraction, calcification was found which remained circumferentially on the annulus.It could be reasonably assumed that the annulus was not decalcified or was only partially decalcified at the time of crown valve implant.After removal of the calcification, sizing was performed, and the perceval valve was ultimately inserted.The native valve was tricuspid, it was not stenotic or steno-insufficient and no abnormal geometries were found in the patient¿s annulus.Bsa was reported as 1.5.Surgeon¿s comment on the event was that the removed crown19 valve had not undergone svd, and it was suspected that there was only pvl.As per medical judgement, when ligating crown19 prosthesis, the stent was pushed in too hard, which may have caused the apex of the valve to fall down.Patient outcome was good after the reoperation.

• Brand Name: CROWN PRT PERICARDIAL 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: 18422161
• MDR Text Key: 331667370
• Report Number: 3004478276-2023-00222
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)210731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2018
• 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