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	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of an intra-operative explant of a perceval plus size xl that occurred on (b)(6) 2025.Reportedly, a ct scan was initially used to assess the anatomy and guide valve sizing, which was followed by tactile sizing.Based on these evaluations, an xl perceval plus valve was selected to be implanted.However, after closure of the aortotomy and under transesophageal echocardiography (tee), a significant central leak was observed.As a result, the perceval plus valve was explanted, and a sutured inspiris valve size 25 was implanted in the patient.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.Manufacturer is pending receipt of the device to perform further investigation on the device.

• 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
• MDR Report Key: 22111079
• Report Number: 3019892983-2025-01009
• Device Sequence Number: 7175488
• Product Code: LWR
• UDI-Device Identifier: 08022057015396
• UDI-Public: (01)08022057015396(240)PVF-XL(17)261209
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2025
• Report Date (Section F): 05/01/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• 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: 61 YR
• Patient Sex: Male