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

Model Number	PVF-M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	10/14/2025
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.The device remains implanted and therefore is not accessible for testing.As such, further investigation cannot be performed.Based on the available information, it is not possible to definitively determine the root cause of the complete atrioventricular block onset.However, the document review did not identify any manufacturing deficiencies in the device.It should be noted that conduction disorders are common in patients with aortic valve diseases, often leading to the need for permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conduction disease, which, based on the available information, was not present though in the patient's medical history, and preoperative aortic regurgitation.Therefore, the reported event is a known inherent risk of the procedure and is listed among the potential adverse events in the percival ifu.
Event or Problem Description
The manufacturer was informed of the following event through mantra study.Based on the information received, a percival plus valve (pvf-m) was implanted in the patient on (b)(6) 2025.On the same day, the patient developed a complete atrioventricular block, which persisted until (b)(6) 2025.As the condition did not resolve, a permanent pacemaker was implanted on (b)(6) 2025.The reported outcome is "recovered/resolved w.Sequelae".The patient experienced a stroke on postoperative day 1, which, based on the available information, was attributed to bilateral carotid stenosis diagnosed after the event.Based on the available information, the patient's medical history included coronary artery disease, systemic hypertension, dyslipidaemia, pulmonary hypertension, and a resolved malignancy.Atrial flutter was reported and surgically treated in 2024.The patient was classified as nyha functional class ii.No device deficiency has been reported from the site.The site assessed the event as possibly related to the device and probably related to the implanting procedure.

• 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: 23533162
• Report Number: 3004478276-2025-00182
• Device Sequence Number: 9020924
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)290713
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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-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: 10/14/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2025
• 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; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 72 KG