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	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing manufacturing records and retrieving further information from the facility, and will submit follow-up report upon availability of new, relevant details.
Event or Problem Description
On (b)(6) 2025, a perceval plus valve was attempted to be implanted during an avr + cabg procedure.Reportedly.A large size was used; however, a medium size was referenced.The valve was implanted, then removed due to a paravalvular leak, with another device (unknown model, size) was implanted instead.No further information is available.
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 facility, and will submit follow-up report upon availability of new, relevant details.
Additional Manufacturer Narrative
Updated sections a2, a3a, a4, 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.From the document review performed, no manufacturing deficiencies were noted.Based on the information available, patient was bicuspid and had a heavily calcified annulus.Further calcification was also performed prior to implant of the inspiris valve.As such, despite the limited information available, based on the event description the cause can be reasonably attributed to insufficient decalcification and mis-sizing (use error).
Event or Problem Description
On (b)(6) 2025, a perceval plus valve size l was attempted to be implanted through full sternotomy during an avr+cabg procedure.Reportedly, a large size was used; however, a medium size was referenced.The valve was implanted, then removed due to a paravalvular leak, and edwards inspiris size 23 was implanted instead.Based on the further information received, distal was performed first, then valve was implanted, then proximal was performed.The valve was bicuspid class 1, and heavily calcified.Approximately 60 min was added to the procedure and further deacidification was performed prior to implant of the second valve.Reportedly, patient had a long pump run during the surgery, patient experienced av block post op, had to go through treatment for acute respiratory distress, pulmonary edema, right plural effusion drains, febrile, pneumonia, and large aspiration pneumonia.Patient was on ventilator in (b)(6) 2026 and is currently in ccu currently.

• 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: 23889344
• Report Number: 3004478276-2025-00196
• Device Sequence Number: 11938787
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)290104
• 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: 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,Followup
• Report Date (Section B): 03/07/2026

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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/06/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/03/2026; 03/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2025
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 55 KG