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

Model Number	PVF-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury

• 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: 50909495
• Report Number: 3019892983-2026-00007
• Device Sequence Number: 6076805
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2026
• Report Date (Section F): 09/26/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2026
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2026
• Date Device Manufactured: 07/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 154 LB