MAUDE Adverse Event Report: Corcym Canada Corp. Perceval Plus Sutureless Aortic Heart Valve; Tissue Heart Valve

Model Number	PVF-M
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of an intraoperative explant involving a perceval plus valve.Based on the information received, on (b)(6) 2026, the patient underwent avr + cabg.During sizing, the medium (m) white sizer passed through the annulus with slight resistance, while the large (l) white sizer could not pass through the annulus.Therefore, a perceval plus size m valve was selected.Patient¿s annulus size was 25mm.After aortic cross-clamp removal, intraoperative tee revealed severe paravalvular leakage (pvl) near the left-noncoronary (ln) commissure.Consequently, the perceval plus m valve was explanted and was replaced with a 19-mm magna valve.The operation was then completed successfully.Approximately, 40 minutes was added to the procedure as a result of this complication.The patient remained stable throughout the delay in procedure.
Additional Manufacturer Narrative
Updated sections b4, d9, g3, g6, h2, h3, h6, h11 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.Device has been received from the site.A follow-up report will be submitted upon completion of investigation and/or receipt of new information.
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.A follow-up report will be submitted upon receipt of the device, completion of investigation, and/or availability of new details.

• 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
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040
• MDR Report Key: 50085939
• Report Number: 3004478276-2026-00156
• Device Sequence Number: 21400538
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)300109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2026
• 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 Sex: Unknown