MAUDE Adverse Event Report: Corcym S.r.l. Perceval Plus Sutureless Aortic Heart Valve; Tissue Heart Valve

Model Number	PVF-XL
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of an explant involving a perceval plus heart valve.The following provides a summary of all information currently available to the manufacturer from the healthcare facility.On (b)(6) 2026, the patient underwent coronary artery bypass grafting (cabg) and aortic valve replacement (avr) with a perceval plus size xl bioprosthesis.Subsequently, the patient was evaluated in the postoperative period due to the development of acute pulmonary edema.Echocardiographic examination revealed that the implanted perceval plus valve had become displaced from its original position.Consequently, the patient underwent re-operation on (b)(6) 2026.During the intraoperative assessment, the perceval valve was explanted and examined for potential reimplantation.The explanted valve was attempted to be collapsed and difficulties were encountered as they were not able to fit the valve properly into the delivery system.Subsequent inspection revealed a deformation in the inflow section of the valve.As a result, the valve was replaced with another new perceval plus size xl valve.
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 completion of device investigation and/or availability of additional information.

• 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 S.r.l.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 50943492
• Report Number: 3005687633-2026-00115
• Device Sequence Number: 15859109
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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 Sex: Male