MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-L
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/22/2025
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.Since the device was disposed and was not available for return to the manufacturer, further investigaton on the device could not be performed.However, from the document review performed, no device deficiencies were noted.Since limited information is available, the definitive root cause of the reported event cannot be established at this time.It should be noted that due to the complexity of the procedure, it is reasonable to assume that the observed perivalvular leak could be related to positioning difficulties.Should further information be received in the future, a follow up report will be submitted.
Event or Problem Description
The manufacturer was informed of an intraoperative explant involving a perceval plus sutureless aortic heart valve, size l (pvf-l), which occurred on (b)(6) 2025.Reports indicate that a wheat procedure was carried out via a full sternotomy, involving the replacement of both the aortic valve and a portion of the ascending aorta.Following implantation, a paravalvular leak was detected, leading to the removal of the pvf-l valve and its replacement with a sutured inspiris valve size 23.Consequently, the duration of the surgery was extended by approximately 35-40 minutes.According to the information received, the valve's collapsing and implantation proceeded without issues.The explanted prosthesis was disposed of at the site, making it unavailable for return to the manufacturer for further assessment.

• 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 ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 22294348
• Report Number: 3005687633-2025-00118
• Device Sequence Number: 8310386
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)290314
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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-L
• Device Catalogue Number: PVF-L
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2025
• 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: Unknown