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

Model Number	PVF-S
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/02/2025
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.As the device was discarded at the hospital, the manufacturer is unable to conduct a direct examination of the prosthesis involved.The manufacturer is following up with the healthcare facility to retrieve additional information on the circumstances surrounding the event.A follow up report will be submitted upon receipt of any new information.
Event or Problem Description
The manufacturer was informed of an intra-operative explant of a perceval plus prosthesis occurred on (b)(6) 2025 during an avr case performed through full sternotomy.According to the information received, following the sizing procedure, it was determined that a valve size s was suitable for the patient and a perceval plus heart valve size s was implanted accordingly.However, severe paravalvular leakage (pvl) was observed on intra-operative echocardiography, and the valve was subsequently explanted.The surgery was then completed using a conventional valve from a different manufacturer (unknown model and serial number) without reported complications on the patient, who remained relatively stable throughout the procedure.The hospital reported that the device in question was discarded on-site due to the patient's infection, and therefore will not be available for further analysis.The manufacturer was also informed that the healthcare facility will not disclose any information regarding the patient.Reportedly, no positioning problem was noted while implanting the perceval prosthesis, and the native valve was tricuspid.

• 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 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 22673356
• Report Number: 3005687633-2025-00123
• Device Sequence Number: 3677569
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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?: 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: 07/02/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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 Sex: Male