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

Model Number	S5-027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	11/05/2025
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.In conclusion, since the device was not returned to the manufacturer, additional evaluation of the valve was not performed.Based on the late onset of the endocarditis (at least 2 years after valve implant,) this event classifies as late pve which, according to scientific literature, occurs mostly due to community-acquired infection [ref.Piper c, körfer r, horstkotte d.Prosthetic valve endocarditis.Heart.2001 may;85(5):590-3].Furthermore, no manufacturing, nor sterilization or quality deficits were identified from the document review performed.As such, based on the information available, the root cause of the reported event cannot be attributed to the device itself but is more likely related to patient-specific factors, specifically the development of the root abscess that necessitated valve explantation.
Event or Problem Description
The manufacturer was notified of an explant involving a carbomedics top hat mechanical aortic valve.The following provides a summary of all information currently available to the manufacturer from patient/device tracking and the site.On (b)(6) 2022, a carbomedics top hat aortic valve, s5-027, was implanted in a 24 valsalva graft in the patient.Later the patient developed osteomyelitis from a toe which was amputated, mrsa bacteremia, and tee and ct scan showed the presence of a root abscess.Due to endocarditis and the root abscess, after about 3 years from implant, on (b)(6) 2025 the valve was explanted and replaced with a 25mm magna ease valve while the root was replaced with a 24 cardial root.After the reoperation, tee showed normal functioning bioprosthesis no paravalvular leak and preserved ventricular function.Mean gradient was 19 with a very hyperdynamic heart.The patient has recovered and was discharged on (b)(6) 2025.The site discarded the valve after the procedure.

• 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: 24520304
• Report Number: 3005687633-2026-00104
• Device Sequence Number: 15561042
• Product Code: LWQ
• UDI-Device Identifier: 08022057012937
• UDI-Public: (01)08022057012937(240)S5-027(17)270726
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/05/2026

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: S5-027
• Device Catalogue Number: S5-027
• 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: 02/03/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2022
• 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: Male