MAUDE Adverse Event Report: Corcym Canada Corp. Perceval Plus Sutureless Aortic Heart Valve; Tissue Heart Valve

Model Number	PVF-S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of an explant (redo surgery) involving a perceval plus valve.Based on the information received, the perceval plus valve size s was implanted via mics-avr on (b)(6)2025.Symptoms of as/r (aortic stenosis/regurgitation) were observed starting around three or four months ago.By june, the as had progressed, and as one valve leaflet was immobile, a reoperation was performed on (b)(6)2026.It was determined that the leaflet corresponding to the right coronary cusp was immobile because it was folded outward and had become rigid due to degeneration.As the area near the immobile valve leaflets had become difficult to excise due to pannus proliferation and other factors, the stent in that region was cut, and the perceval plus was removed.After explanting the perceval plus, the inspiris 19 was implanted, and the surgery was concluded.The patient presents no factors, such as dialysis, that would cause degeneration of the valve leaflets.There was no reported adverse event or outcome for the patient.
Additional Manufacturer Narrative
Updated sections b4, d9, g3, g6, h2, h3, h6, h11 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.Device has been received from the site.A follow-up report will be submitted upon completion of investigation and/or receipt of new information.
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.A follow-up report will be submitted upon receipt of the device, completion of investigation, and/or receipt of new information.

• Brand Name: Perceval Plus Sutureless Aortic Heart Valve
• Common Device Name: Tissue Heart Valve
• Manufacturer (Section D): Corcym Canada Corp.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): Corcym Canada Corp.; 5005 north fraser way; burnaby, bc V5J 5 M1
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040
• MDR Report Key: 50085798
• Report Number: 3004478276-2026-00155
• Device Sequence Number: 9804015
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)280813
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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 Age: 79 YR
• Patient Sex: Female