MAUDE Adverse Event Report: CORCYM S.R.L. OPTIFORM PROSTHETIC MITRAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer became aware of the following event through device tracking department.Based on the information on the patient registration forms, a carbomedics optiform mitral valve f7-029 was implanted in the patient on (b)(6) 2024.After about 1 year, the device was replaced with a similar device, but a smaller size f7-027 on (b)(6) 2025.No further information has been received from the site about any device dysfunction or adverse patient outcome at this time.
Additional Manufacturer Narrative
Manufacturer is reviewing production records and retrieving further information from the healthcare facility, and will send follow-up report upon availability of new, relevant details.
Additional Manufacturer Narrative
Updated sections b4, b5, g3, g6, h2, h6, h11.Corrected h6 - clinical code.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.From the document review performed, no manufacturing deficiencies were noted.Based on the information available, the optiform valve size 29 was explanted and optiform valve size 27 was implanted instead.As such, this can point to a possible mis-sizing (use error) as a cause of this event.Furthermore, it should be noted that prosthetic thrombosis causing valve obstruction and/or regurgitation is a well-known adverse event in patients with prosthetic heart valves and patients with mechanical prostheses require lifelong anticoagulation with warfarin due to the increased risk of thromboembolic events.Based on the manufacturer¿s experience, it cannot be excluded that patient related factors or poor compliance to the anticoagulation therapy could have contributed to the gradient increase observed in this case.But since limited information is available in this regard, this cannot ultimately be confirmed.
Event or Problem Description
Manufacturer was informed of the following event through device tracking department.Based on the information on the patient registration forms, a carbomedics optiform mitral valve f7-029 was implanted in the patient on (b)(6) 2024.On (b)(6) 2025, the device was replaced with a similar but smaller size valve f7-027.Based on the further information received, preoperative diagnosis showed prosthetic mitral valve thrombosis, and severe tricuspid valve regurgitation.The re-intervention procedure included redo sternotomy, redo mitral valve replacement with a 27 mm carbomedics optiform mechanical valve, and tricuspid valve repair with a 28 mm medtronic contour 3d tricuspid annuloplasty ring.Reportedly when mitral valve was exposed, there was a significant amount of chronic thrombi on the prosthetic valve, and the lateral leaflet was completely stuck in the closed position.The prosthetic valve was resected, the pledgets and sutures were retrieved, the lateral component of the posterior mitral leaflet that had been preserved during the original operation was also resected.Then, a 27 mm carbomedics optiform mechanical valve was implanted as a replacement valve.The procedure was completed with no complications.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 23613644
• Report Number: 3005687633-2025-00137
• Device Sequence Number: 21074892
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)261005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P900060S019
• 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,Followup
• Report Date (Section B): 02/26/2026

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 Expiration Date: 10/05/2026
• Device Model Number: CPHV
• Device Catalogue Number: F7-029
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2021
• 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: 69 YR
• Patient Sex: Female