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

Model Number	PVF-S
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 20225, a perceval plus valve pvf-s was implanted at mics avr surgery.After implanted, slight central leak was noted but the patient was weaned off of the cardiopulmonary support after it was determined that there was no problem.The regurgitation subsequently increased, and the right valve leaflet was not moving, which was confirmed by echo.As such, the chest was reopened.The percival valve was removed, and epic 19 mm was implanted instead.No further information is available at this time.
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing the production record of the device as well as investigating on the device.A follow up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6.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.Steady flow test review was also performed.The images demonstrated the acceptable opened and closed leaflet performance of the percival pvf-s 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 dedicated procedure at the time of release.Device was returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications, although leaflet #2 was found to be slightly more tensioned than the others.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 2.43 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 4.0 % and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent size.Regarding the full coaptation of the leaflets, no anomalies were observed during the open/close cycle in normotensive conditions.This is further confirmed from the comparison with the images of the test carried out before the release of the product (steady flow test), which show no evidence of anomalous behavior, while a substantial correspondence can be observed in the morphology of the opening/closing leaflets.Hypotensive conditions, though not indicative of normal functioning, are utilized to test and evaluate potential valvular behavior during the weaning phase of the intervention.Under these specific conditions, a slight central leak was detected.The tests conducted in accordance with iso 5840 mandate that the valve be maintained in a circular configuration and normotensive condition to ensure compliance with the standard.To explore the issue under a worst-case scenario, the valve was also tested in a d-shaped form and hypotensive condition.While its performance remained acceptable, it was not entirely flawless.Therefore, it is reasonable to assume that the valve¿s suboptimal performance, as observed in the reported event, may have been influenced by a complex anatomical structure and implantation within an unusually shaped annulus in the patient, and a phase in which cardiac activity had not yet fully recovered.Based on the analyses performed, the reported event cannot be explained by any factor intrinsic in the involved device because the claimed issues were not observed during the test conducted out under iso 5840 conditions.Further investigation, aimed at replicating the reported anomaly, succeeded only under testing requirements out of those included in iso 5840 (i.E., d-shaped configuration and hypotensive conditions).Furthermore, from the document review performed, no manufacturing deficiencies were noted.Therefore, it cannot be excluded that the observed central leak was a result of the patient¿s peculiar anatomical structure and hypotensive pressure condition in the immediate post-implant phase, when cardiac activity had not yet fully recovered.Nevertheless, since limited information is available in this regard, the exact root cause cannot ultimately be confirmed.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: 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: 22023061
• Report Number: 3004478276-2025-00135
• Device Sequence Number: 9483576
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)281013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2024
• 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: 87 YR
• Patient Sex: Female