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

Model Number	PVF-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed that a perceval plus valve size s was implanted in the patient on (b)(6) 2025.Reportedly, the valve was explanted the day after, on (b)(6) 2025.According to the report provided, the prosthesis had been implanted during a double valve replacement (dvr) procedure, following a mitral valve replacement using a valve from an epic 29 mm valve.Based on the information received, difficulties were encountered during the deployment of the perceval valve, with significant force required to operate the relyon delivery system.Despite this, the procedure was completed successfully after confirming that the perceval valve was properly aligned.On the first postoperative day, an echocardiogram revealed a paravalvular leak (pvl) associated with the perceval prosthesis.A subsequent ct scan confirmed the presence of stent infolding.Therefore, the perceval prosthesis was explanted and replaced with mosaic size 19 valve.
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 is retrieving further information from the site.A follow-up report will be provided upon availability of new, relevant details.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6.Manufacturer attempted to follow up with the site, but no further information has yet been received.Since limited information is available and the device was not returned for further investigation, a definitive root cause of the reported event cannot be established at this time.Should further information be received in the future, a follow up report will be provided.

• 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: 22236609
• Report Number: 3004478276-2025-00148
• Device Sequence Number: 21076875
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)290105
• 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): 01/13/2026

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?: No
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2025
• 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: 81 YR
• Patient Sex: Female