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

Model Number	PVF-M
Medical Device Problem Codes	Degraded (1153); Gradient Increase (1270)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	08/19/2026
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: 50740616
• Report Number: 3004478276-2026-00164
• Device Sequence Number: 8861817
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)250219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Expiration Date: 02/19/2025
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: No
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 220 LB