MAUDE Adverse Event Report: Corcym S.r.l. Perceval Sutureless Aortic Heart Valve; Heart-Valve, Non-Allograft Tissue

Model Number	PVS23
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of the intraoperative explant of a perceval s size m valve.The following provides a comprehensive summary of all information currently available to the manufacturer.On (b)(6) 2026, an attempt was made to implant a perceval s valve, size m (pvs23).However, stent infolding was observed during the procedure.Consequently, the valve was explanted and replaced with another perceval valve of unknown size.No further information is available at this time.
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 manufacturer will submit follow-up report upon availability of new details from healthcare facility and/or completion of device investigation.

• Brand Name: Perceval Sutureless Aortic Heart Valve
• Common Device Name: Heart-Valve, Non-Allograft Tissue
• 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: 50233393
• Report Number: 3004478276-2026-00158
• Device Sequence Number: 18710523
• Product Code: LWR
• UDI-Device Identifier: 08022057014702
• UDI-Public: (01)08022057014702(240)ICV1209(17)300304
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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: PVS23
• Device Catalogue Number: PVS23
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/26/2026; 09/30/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/25/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2026
• 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: Unknown