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

Model Number PVS23

Device Problems Collapse (1099); Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, 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 #icv1209) perceval heart valve at the time of manufacture and release.Steady flow test review was also performed.The images of the valve demonstrate the acceptable opened and closed leaflet performance of the perceval pvs23 sn# (b)(4).No anomalies were observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in dedicated procedure.The manufacturer will submit a follow up report upon receipt of the device or additional information.

Event Description

The manufacturer was informed that after the aorta was closed following routine aortic valve replacement with pvs23, subsequent echo showed regurgitation from the valve.As reported, during the inspection of the valve after removal, it was noticed that the valve strut was not uniform.Another device was ultimately implanted in the patient.No more information is currently available.

Event Description

The manufacturer was informed that after the aorta was closed following routine aortic valve replacement with pvs23, subsequent echo showed regurgitation from the valve.As reported, during the review of the valve, it was noticed that the valve strut was not uniform.Another device was ultimately implanted in the patient.Based on the additional information received, there was a central and paravalvular leak which was severe in nature.No impact on the patient other than prolongation of the surgery has been reported.Patient remaine4d stable through out the procedure.Reportedly, there were significant calcifications of the root and the valve bucked inwards creating significant pv and intravalvular leak.

Manufacturer Narrative

The device was returned to the manufacturer.After decontamination, the valve was visually inspected and, according to the specifications, no particular element of non-conformity that could be related to possible pre-existing defects, has been highlighted.The collapsing procedure performed with the returned valve and a demo accessory kit was completed with no issue and the valve was correctly collapsed.During the simulation of the valve deployment in silicon aortic roots #23, no problems were encountered and during the ballooning phase: the sealing at the annulus level was guaranteed; thus, the valve 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.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.The hydrodynamic testing conducted on the pvs 23/m was performed.The effective orifice area (eoa) of cardiac output and mean aortic pressure were well above the minimum requirement and the regurgitant fraction was below the requirement for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device since no regurgitation and no open/close anomalies were observed during the functional test under hydrodynamic testing conditions.Comparing the images of the fluidic test performed on the returned valve, with the images of release test (steady flow test), a slight difference can be observed in the opening of the leaflet.This particular geometry, more visible in hypotensive conditions, was not found in the images of the steady flow test, suggesting that it may be due to small deformations induced during the explant phases of the prosthesis itself.It is not possible to establish whether this is in line with what was observed and reported by the customer; however, this aspect does not alter in any way the closing configuration of the leaflets themselves.As such, it cannot in any way be attributed as a possible cause of the complained regurgitation observed at the echo.Based on the manufacturer's experience of similar cases, it is possible that the root cause of the reported event was attributed to mis-sizing or patient's anatomy.However, since limited information is available in this regards, this cannot be ultimately confirmed.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2.To perform further investigation on the case, a complete manufacturing and material records review for the stent has also been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.There is no change in the conclusion and the conclusion will remain the same.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; buraby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14347612
• MDR Text Key: 291310515
• Report Number: 3004478276-2022-00146
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)251124
• 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: 07/08/2022

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: PVS23
• Device Catalogue Number: ICV1209
• 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: 04/12/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/20/2022; 06/19/2022
• Supplement Dates FDA Received: 06/16/2022; 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• 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