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

Model Number	PVF-M
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer is reviewing production records and retrieving other further information from the healthcare facility; will submit follow-up report upon availability of new, relevant details.
Event or Problem Description
Manufacturer was informed about an intraoperative explant of a perceval plus valve, pvf-m that occurred on (b)(6) 2025.The valve was implanted into a bicuspid aortic valve with elliptical shape, pvl were present on echo.As such, patient was reopened and the valve was removed.Reportedly, patient was not a good candidate due to particular anatomy.No other further information has been received from the site at this time.
Additional Manufacturer Narrative
Updated sections b4, 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.Manufacturer is retrieving further information from the healthcare facility; and will submit follow-up report upon availability of new, relevant details.
Additional Manufacturer Narrative
Updated sections: a2 (date of birth), b4, b5, 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 limited information is 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 and medical judgement received from the site, the valve was implanted in the bicuspid aortic valve with elliptical shape, and the patient was not a good candidate due to particular anatomy.As such, cause of the event can be related to the patient anatomy.
Event or Problem Description
Manufacturer was informed about an intraoperative explant of a perceval plus valve, pvf-m (serial # (b)(6)) that occurred on (b)(6) 2025.The valve was implanted into a bicuspid aortic valve with elliptical shape, pvl were present on echo.As such, patient was reopened and the valve was removed.Reportedly, patient was not a good candidate due to particular anatomy.Based on the further information received, there was a paravalvular leak but no central leak.There was no migration, dislodgement, or mis-sizing.Furthermore, it was reported that patient did not experience an adverse event.

• 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, bc
• 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: 23667686
• Report Number: 3004478276-2025-00190
• Device Sequence Number: 15681172
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)291008
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 04/02/2026

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?: 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 03/04/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/08/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 59 KG