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	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/23/2025
Type of Reportable Event	Death
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.Manufacturer is following up to gather more information regarding the reported event.A follow up report will be provided upon receipt of any further information.
Event or Problem Description
Manufacturer was informed of the following event: reportedly, on (b)(6) 2025, patient was prepared for bypass and aortic valve replacement.After completing multiple bypasses, which were reported as challenging due to very delicate tissue, the aorta was opened, the leaflets and calcium were removed, and the annulus was sized as a small perceval plus valve.The valve was collapsed, implanted, and the ballooning was performed.Then, they started to rewarm the patient and come off bypass, however it was seen on the echo that there were several leaks around the valve, and it was sitting above the annulus in the sinuses.They went back on bypass and removed the valve.As such, the annulus was checked and a bit more calcium was removed.The valve was loaded on the holder again and reimplanted taking more careful steps to ensure proper implant and deployment of the valve.Further checks for valve seating position were performed, and ballooning was completed.Then, they started to rewarm and slowly come off bypass.Reportedly, on echo evaluation the valve had no leaks and was seen to be in the correct position with good coaptation of the leaflets.The patient's right ventricle was said to be ballooning out and hemodynamics and blood pressure were not stable.Thus, they went back on bypass to gain control and attempt to come off slower with managing the volumes.In total, patient was on bypass for over 4 hours and cross clamp for over 1 hour.It was reported that the patient ultimately passed away.Patient medical history was reported as: coronary artery disease, aortic stenosis, end stage renal disease, obesity, obstructive sleep apnea, type 2 diabetes, hypertension, hypothyroidism, dyslipidemia.
Event or Problem Description
Manufacturer was informed of the following event: reportedly, on (b)(6) 2025, patient was prepared for bypass and aortic valve replacement.After completing multiple bypasses, which were reported as challenging due to very delicate tissue, the aorta was opened, the leaflets and calcium were removed, and the annulus was sized as a small perceval plus valve.The valve was collapsed, implanted, and the ballooning was performed.Then, they started to rewarm the patient and come off bypass, however it was seen on the echo that there were several leaks around the valve, and it was sitting above the annulus in the sinuses.They went back on bypass and removed the valve.As such, the annulus was checked and a bit more calcium was removed.The valve was loaded on the holder again and reimplanted taking more careful steps to ensure proper implant and deployment of the valve.Further checks for valve seating position were performed, and ballooning was completed.Then, they started to rewarm and slowly come off bypass.Reportedly, on echo evaluation the valve had no leaks and was seen to be in the correct position with good coaptation of the leaflets.The patient's right ventricle was said to be ballooning out and hemodynamics and blood pressure were not stable.Thus, they went back on bypass to gain control and attempt to come off slower with managing the volumes.In total, patient was on bypass for over 4 hours and cross clamp for over 1 hour.It was reported that the patient ultimately passed away.Patient medical history was reported as: coronary artery disease, aortic stenosis, end stage renal disease, obesity, obstructive sleep apnea, type 2 diabetes, hypertension, hypothyroidism, dyslipidemia.
Additional Manufacturer Narrative
Updated sections b4, b5, g3, g6, h2, h6.Manufacturer attempted to follow up with the site but was informed that no further information will be provided.Based on the information available, the definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.From the information available, the cause of the event could possibly be related to malpositioning, difficult procedure and/or patient anatomy, but this cannot ultimately be confirmed.

• 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: 22073417
• Report Number: 3004478276-2025-00136
• Device Sequence Number: 13086744
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)280804
• 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
• 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): 11/27/2025

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: 04/24/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2024
• 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: Death
• Patient Age: 63 YR
• Patient Sex: Female