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

Model Number	F7-027
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
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 manufacturer has received the device and is retrieving more information from the healthcare facility; a follow-up report will be submitted upon availability of new information and after completion of the device's investigation.
Event or Problem Description
The manufacturer was notified of the intraoperative explant of a carbomedics optiform mitral valve in size 27.The following provides a comprehensive summary of all information currently available to the manufacturer.On (b)(6) 2025, during a mitral valve surgery using the carbomedics optiform mitral heart valve, the surgeon discovered on echo that one of the leaflets was not opening properly.Further attempts still ended in failure, therefore the valve was removed and replaced with a medtronic heart valve.The echo showed normal function.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h3, h6, h11.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 prosthesis was returned to the manufacturer, and it was received in the explant kit inside the inner barrier of the original sterile packaging.Both the valve and the holder were received in dry condition.Upon visual and tactile inspection, the leaflets appeared free to move throughout the full range of motion, transitioning normally between the closed and open positions.At preliminary examination, no obvious signs of obstruction or mechanical interference were identified.After decontamination and cleaning, the valve underwent detailed visual inspection.No anomalies were identified, other than minor marks consistent with suture passage and removal, which are in line with standard implantation and reasonable explant maneuvers.The sewing cuff was removed for hydrodynamic testing.The hydrodynamic testing conducted on the subassembly of the valve confirmed a normal leaflet kinematic showing a correct movement of the leaflets; no anomalies were observed during the open/close cycle of the pulsatile hydrodynamic test in both normotensive and hypotensive pressure conditions.The effective orifice area (eoa) at 70 bpm, c.O.Of 5.0 l/min and m.A.P.Of 100 mmhg is 2.27 cm2, above the iso 5840 minimum requirement 1.70 cm2; the regurgitant fraction (rf%), under the same testing conditions, is 5.5%, below the iso 5840 requirement of 15%.No anomalies were observed during the open/close cycle.In conclusion, a malfunction of the device can be excluded as the root cause of the reported event, as based on the experimental evaluation performed, no mechanical malfunction could be reproduced in our laboratories.In addition, the document review did not reveal any manufacturing deficiencies.As no further information about the event was provided despite the follow up attempts, it was not possible to determine a definitive root cause for the reported issue.

• 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 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: 24302364
• Report Number: 3005687633-2026-00098
• Device Sequence Number: 20119452
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)300224
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/23/2026

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: F7-027
• Device Catalogue Number: F7-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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
• Patient Sex: Unknown