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

Model Number	PVF-M
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
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 following up with the involved healthcare facility to obtain further details.A follow up report will be provided upon receipt of any further information.Manufacturer is retrieving further information about the event and will submit follow-up report upon availability of relevant details.
Event or Problem Description
The manufacturer was notified of an event related to a perceval plus sutureless heart valve pvf-m which was implanted on (b)(6) 2025.Reportedly, the implantation procedure was successfully completed without complications, and no paravalvular leak (pvl) was detected at the time.However, the echocardiogram performed during implantation raised concerns about the non-coronary cusp (ncc), which appeared to exhibit restricted or absent motion.A postoperative ct scan conducted on (b)(6) confirmed that the ncc was indeed not moving, although no pvl was detected.No echocardiographic evaluation was performed at the time of the ct scan.No explant surgery has been scheduled at this time.Reportedly, no positioning difficulties, mis-sizing, or abnormal patient's annulus was noted during the surgery.No further information is available at this time.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h6, h11 the review of the steady flow test images was performed.The images demonstrated the acceptable opened and closed leaflet performance of the perceval pvf-m 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.Since the device is still implanted and, as such, not accessible for testing, the manufacturer couldn't perform any further direct investigation on the involved prosthesis.From the review of the documentation, no manufacturing issues were identified.As the device is not available for direct evaluation, it is not possible to determine a definitive root cause for the reported complaint.No diagnostic images showing the ipomobile leaflet were shared, and despite multiple attempts to obtain further information regarding the patient's condition, no response has been received.

• 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 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: 22195033
• Report Number: 3004478276-2025-00141
• Device Sequence Number: 9739150
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)290221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/13/2025

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-M
• Device Catalogue Number: PVF-M
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 57 KG