MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	S5-025
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2025
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.Both top-hat valves involved in the reported event were not returned to the manufacturer; therefore, a device evaluation could not be performed.Given the late onset of endocarditis (approximately six months after valve implantation), the event is classified as late prosthetic valve endocarditis (pve), which, according to scientific literature, most commonly results from community-acquired infections [ref.Piper c, körfer r, horstkotte d.Prosthetic valve endocarditis.Heart.2001 may;85(5):590¿3].Furthermore, the document review did not identify any issues related to manufacturing, sterilization, or product quality.As reported, the s5-025 valve was explanted and replaced with a smaller size (s5-023).It is therefore reasonable to conclude that the explantation was related to mis-sizing (use error).The subsequent death of the patient was attributed by the surgeon to multi-organ failure that occurred after weaning from ecmo, and not to the implanted s5-023 valve.Consequently, the patient¿s death is reasonably attributable to patient-specific factors.
Event or Problem Description
The manufacturer was notified of an explant involving a carbomedics top hat aortic valve.The following provides a summary of all information currently available to the manufacturer from patient/device tracking.On (b)(6) 2024, a carbomedics top hat aortic valve, s5-025, was implanted in a patient.Reportedly, the patient developed endocarditis and after about 6 months, the valve was explanted and replaced with a similar but smaller size valve s5-023 on (b)(6) 2025.After the redo procedure the patient was put on ecmo, and later weaned off.The patient unfortunately passed away due to multi organ failure.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• 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: 24505579
• Report Number: 3005687633-2026-00103
• Device Sequence Number: 18751964
• Product Code: LWQ
• UDI-Device Identifier: 08022057012920
• UDI-Public: (01)08022057012920(240)S5-025(17)280818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/04/2026

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: S5-025
• Device Catalogue Number: S5-025
• 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: 02/02/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• 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 Age: 59 YR
• Patient Sex: Unknown