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

Model Number	PVS21
Medical Device Problem Codes	Perivalvular Leak (1457); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Transvalvular Pressure Gradient Increased (4854)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted as a foreign event since a device malfunction cannot be excluded based on the available information.The manufacturer will submit a follow report upon receipt of any new information or at the completion of the investigation.
Event or Problem Description
The manufacturer was notified of a perceval s valve explant that occurred on the first post-operative day due to a paravalvular leak (pvl) and increased gradients (40 mmhg).Reportedly, the prosthesis was implanted during an isolated avr surgery, with no difficulties encountered in collapsing and positioning the device according to the information received, post-dilation of the inflow ring was performed after the complete deployment of the prosthesis, as prescribed by the ifu, and no complications were experienced during the surgery.Based on the information received, the patient's native valve was tricuspid and steno-insufficient, with predominant aortic stenosis.Although the annulus geometry was not abnormal, there was some degree of calcification of the mitral annulus.As reported, the day after surgery it was decided to reintervene on the patient and replace the perceval valve with a conventional bioprosthesis (corcym crown 21 mm) due to the paravalvular leak and increased pressure gradients, which left the patient in critical condition.The coronary arteries were reported to be permeable.According to the medical judgement received, the pvl was caused by a deformation of the perceval stent, confirmed through fluoroscopic imaging, which was induced by a calcium protrusion that was not deemed necessary to remove during surgery.As per additional information received, during the replacement surgery, the patient experienced difficulty exiting the extracorporeal circulation (cpb), leading to a double coronary bypass to address a potential myocardial ischemia event.As reported, the patient is currently ventilated through a tracheostomy and sedated with dexmedetomidine.Hemodynamic and inflammatory parameters are controlled.Complications include a subdural subacute hematoma of small to medium size, which does not currently require drainage, and multiple microhemorrhages in the frontal lobe.
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.The manufacturer will submit an additional follow up report upon receipt of any new information or at the completion of the investigation.
Event or Problem Description
The manufacturer was notified of a perceval s valve explant that occurred on the first post-operative day due to a paravalvular leak (pvl) and increased gradients (40 mmhg).Reportedly, the prosthesis was implanted during an isolated avr surgery, with no difficulties encountered in collapsing and positioning the device.According to the information received, post-dilation of the inflow ring was performed after the complete deployment of the prosthesis, as prescribed by the ifu, and no complications were experienced during the surgery.Based on the information received, the patient's native valve was tricuspid and steno-insufficient, with predominant aortic stenosis.Although the annulus geometry was not abnormal, there was some degree of calcification of the mitral annulus.As reported, the day after surgery it was decided to reintervene on the patient and replace the perceval valve with a conventional bioprosthesis (corcym crown 21 mm) due to the paravalvular leak and increased pressure gradients, which left the patient in critical condition.The coronary arteries were reported to be permeable.According to the medical judgement received, the pvl was caused by a deformation of the perceval stent, confirmed through fluoroscopic imaging, which was induced by a calcium protrusion that was not deemed necessary to remove during surgery.As per additional information received, during the replacement surgery, the patient experienced difficulty exiting the extracorporeal circulation (cpb), leading to a double coronary bypass to address a potential myocardial ischemia event.Reportedly, as of (b)(6) 2024.The patient was ventilated through a tracheostomy and sedated with dexmedetomidine.Hemodynamic and inflammatory parameters were controlled.Complications included a subdural subacute hematoma of small to medium size, which was not requiring drainage at that time, and multiple microhemorrhages in the frontal lobe.As per further information received, the patient passed away on (b)(6) 2025.The manufacturer is following up with the site to retrieve additional details on the patient course and reason for patient's death.
Additional Manufacturer Narrative
The perceval valve involved in this event was returned to the manufacturer for analysis and was received in a plastic jar for specimen filled with unknown liquid.The prosthesis appeared in good storage conditions.After decontamination with formalin treatment, the visual inspection, including dimensional verification, confirmed the absence of any macroscopic anomalies and/or pre-existing defects.In order to attempt to reproduce the reported event, a replication of the collapsing phases was performed using the returned valve pvs 21/s and a demo accessory kit.No problems were encountered during the simulation and the replication was completed with a good result.During the simulation of the valve deployment in silicon aortic root #21, no problems were encountered in the release and ballooning phases: the sealing at the annulus level was guaranteed; thus, the valve remained fixed within the annulus.Then, after inserting some water in the aortic root from the outflow side, no paravalvular leaks were observed.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.As an additional test, an external radial force was applied to localized areas to attempt to induce a deformation of the stent component.As a worst-case scenario, the areas between the posts, corresponding to the sinusoidal structures and in front of the respective leaflets, were selected as targets for the application of the force.This test, although empirical, demonstrates that the deformation occurs only following the application of a radial force concentrated in a limited area.Based on our experience, nitinol structures, as in the case of the perceval stent, have a good ability to return to the original geometric configuration.In this specific case, this behavior was confirmed, thus excluding possible quality issues of the stent structure.Based on the analyses carried out, it is possible to exclude any relationship between the reported issue and the quality of the returned device.The visual inspection of the returned prosthesis did not reveal any pre-existing defects.Dimensional verification confirmed that the returned pvs 21/s valve meets specifications.The collapsing replication did not indicate any procedural difficulties.The deployment simulation of the returned valve did not reveal any anomalies, and the prosthesis was well deployed and stably fixed.No paravalvular leaks were observed during the static leak test simulation, further confirming the stability of the positioning and sealing performance.The additional test to induce deformation of the stent excluded any quality issues with the nitinol component.Based on the above, the most reasonable cause of the reported event may be associated with anatomical aspects of the implantation site (e.G., calcium protrusion), confirming the initial evaluation from the implanting surgeon.
Event or Problem Description
The manufacturer was notified of a perceval s valve explant that occurred on the first post-operative day due to a paravalvular leak (pvl) and increased gradients (40 mmhg).Reportedly, the prosthesis was implanted during an isolated avr surgery, with no difficulties encountered in collapsing and positioning the device.According to the information received, post-dilation of the inflow ring was performed after the complete deployment of the prosthesis, as prescribed by the ifu, and no complications were experienced during the surgery.Based on the information received, the patient's native valve was tricuspid and steno-insufficient, with predominant aortic stenosis.Although the annulus geometry was not abnormal, there was some degree of calcification of the mitral annulus.A pre-operative study of the case had been made through ct scan.As reported, the day after surgery it was decided to reintervene on the patient and replace the perceval valve with a conventional bioprosthesis (corcym crown 21 mm) due to the paravalvular leak and increased pressure gradients, which left the patient in critical condition.The coronary arteries were reported to be permeable.According to the medical judgement received, the pvl was caused by a deformation of the perceval stent, confirmed through fluoroscopic imaging, which was induced by a calcium protrusion that was not deemed necessary to remove during the surgery.As per additional information received, during the replacement surgery, the patient experienced difficulty in weaning off extracorporeal circulation (cpb), necessitating a double coronary bypass to address a potential myocardial ischemia event but was ultimately transferred to icu in good hemodynamic conditions.Reportedly, as of (b)(6) 2024 the patient was ventilated through a tracheostomy and sedated with dexmedetomidine.Hemodynamic and inflammatory parameters were controlled.Complications included a subdural subacute hematoma of small to medium size, which was not requiring drainage at that time, and multiple microhemorrhages in the frontal lobe.As per further information received, the patient passed away on (b)(6) 2025 because of multiorgan failure.The manufacturer received a medical judgment indicating that the crown prosthesis ultimately implanted in the patient can be excluded as a cause or contributory factor to the patient¿s death.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 21054964
• Report Number: 3004478276-2025-00109
• Device Sequence Number: 12957554
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)250325
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 02/17/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/11/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female