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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/10/2025
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, the root cause of this event cannot ultimately be established.It should be noted that the analysis of the production records confirmed that the valve satisfied all the specifications at the time of manufacture and release.Moreover, no device deficiency was reported by the site.It should be taken into consideration that the patient had a previous history of atrial flutter which is a known risk factor for stroke.Given that no device deficiencies were identified during the review of the production records, and none were reported by the site, it¿s reasonable to assume that the event was likely caused by other patient¿s medical conditions or the implanting procedure, although this cannot ultimately be confirmed.
Event or Problem Description
The manufacturer was informed of the following event through mantra study.Based on the information received, a perceval plus valve, pvf-m was implanted in the patient on (b)(6) 2025, through median sternotomy.Three cabg procedures were performed as concomitant procedures prior to the perceval valve implantation.Reportedly, the patient experienced a stroke on postoperative day #1, which required close monitoring, including diagnostic examinations and test.Medical judgment received suggests that the stroke could possibly be related to bilateral carotid stenosis, which was diagnosed after the event.The outcome of the event is indicated as recovered/resolved w.Sequelae.Based on the available information, the patient's medical history includes 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, probably related to the implanting procedure and possibly related to other medical conditions.

• 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: 23533059
• Report Number: 3004478276-2025-00181
• Device Sequence Number: 21382927
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 72 KG