MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
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 awaiting the receipt of the device.A follow up report will be provided upon receipt of the device and/or completion of the investigation.
Event or Problem Description
The manufacturer was informed of a failure to implant a pvf-l.Reportedly, the valve was implanted but central ai and pvl was noted when the patient went off pump.Therefore, the prosthesis was explanted and replaced with a different valve.Based on the further information received, the valve was implanted through full sternotomy, the valve was replaced with inspiris 23, concomitant procedure was avr and mvr.Reportedly, there was no impact on the patient and patient remained stable through the prolongation of the surgery.
Additional Manufacturer Narrative
Updated sections b4, b5, d9, g3, g6, h2, 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.Since the device was not returned to the manufacturer, further investigation could not be performed.As such, the definitive root cause of the reported event cannot be established at this time.However, no deficits were identified during the manufacturing documents review.Should further information become available in the future, a follow up report will be provided.
Event or Problem Description
The manufacturer was informed of a failure to implant a pvf-l.Reportedly, the valve was implanted on (b)(6) 2025, but central ai and pvl was noted when the patient went off pump.Therefore, the prosthesis was explanted and replaced with a different valve.Based on the further information received, the valve was implanted through full sternotomy, the valve was replaced with inspiris 23, concomitant procedure was avr and mvr.Reportedly, there was no impact on the patient and patient remained stable through the prolongation of the surgery.The pathology team indicated that the explanted device was inadvertently discarded before it could be preserved.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• 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: 22524249
• Report Number: 3004478276-2025-00156
• Device Sequence Number: 8078543
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)270309
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/27/2026

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-L
• Device Catalogue Number: PVF-L
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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