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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2025
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.Manufacturer attempted to follow up with the site regarding this event but no further information was provided despite multiple attempts of follow up.Since limited information is available, the definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
Manufacturer became aware of the following event through device tracking department.Based on the information on the patient registration form indicated that a perceval plus heart valve, pvf-xl was "explanted/inactive" during the procedure performed on (b)(6) 2025.No further information has been received about any device dysfunction, delay in the procedure or patient outcome at this time.

• 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 ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 22798341
• Report Number: 3004478276-2025-00165
• Device Sequence Number: 8512189
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• UDI-Public: (01)08022057015396(240)PVF-XL(17)281110
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2024
• 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: 71 YR
• Patient Sex: Unknown