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	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
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.The device involved in the reported event has been returned to the manufacturer and a follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The manufacturer was notified of an intraoperative explant involving a perceval plus valve.The following provides a summary of all information currently available.A perceval plus valve pvf-m was attempted to be implanted in a female patient on (b)(6) 2026.During the procedure, a balloon dilatation was performed at 6 bars by another member of the surgical team.The primary surgeon was not directly involved in this step due to the complexity of the procedure but reported that the perfusionist confirmed the pressure used.Subsequently, the valve demonstrated central insufficiency, which led to the decision to explant the device.The patient underwent surgery for combined aortic valve disease (aortic insufficiency and aortic stenosis) along with coronary artery disease requiring bypass surgery.After implantation of the perceval valve, three physicians assessed the resulting valve performance.There was uncertainty among them regarding the severity of the central insufficiency.Intraoperative ultrasound suggested only mild insufficiency; however, due to the lack of consensus and concern over the valve function, the decision was made to proceed with explantation.Following explantation of the perceval valve, a sutured bioprosthetic valve (inspiris, 21 mm) was implanted.This decision was made to ensure a faster and safer conclusion to the surgical procedure.The operating surgeon reported that the patient had a notably short aortic root, which he considered the most probable contributing factor to the central insufficiency.He suggested that the valve may have shifted or ¿slipped¿ into the left sinus of valsalva.Despite this, the valve appeared to be well-positioned immediately after implantation, with good alignment of the valve ring against the aortic annulus.It was also noted that the patient had previously been deemed unsuitable for a transcatheter aortic valve implantation (tavi) due to the anatomical limitation of a short aortic root.

• 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 CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 25314799
• Report Number: 3004478276-2026-00146
• Device Sequence Number: 5295037
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)290902
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 132 LB