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

Model Number	CPHV
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/26/2024
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 manufacturer is following up with the healthcare facility to retrieve additional information on the event and the device involved.A follow up report will be provided upon receipt of any new information or at the completion of the investigation on the returned device.
Event or Problem Description
The manufacturer was informed that an optiform mitral mechanical prosthesis size 31 which was implanted on (b)(6) 2023, was explanted on (b)(6) 2024 due to a significant leak at the hinge of the valve.Reportedly, a new f7-031 valve was implanted as a replacement.
Event or Problem Description
The manufacturer was informed that a carbomedics optiform mitral mechanical prosthesis size 31 (f7-031) which had been implanted on (b)(6) 2023, was explanted on (b)(6) 2024 due to a significant leak at the hinge of the valve.During the initial surgery cabg (4 vessels) had been performed as concomitant procedure.Reportedly, the involved prosthesis was replaced with a new f7-031 prosthesis.No further information is available to the manufacturer at the time of the present report.
Additional Manufacturer Narrative
Updated section.Corrected fields.The explanted prosthesis was returned to the manufacturer for analysis and was received in a plastic jar filled with an unknown liquid solution.The sewing cuff was found completely removed, leaving the external titanium component (stiffening ring) totally exposed.The leaflets were freely moving in both full open and closed positions.The orifice had a chipped part on the outflow side at the contact area between the leaflet and its internal portion.After decontamination, a visual inspection was performed , confirming that the damaged areas were caused by contact with surgical instruments, likely occurring during the explant/removal manoeuvre, even if a damage occurred while handling the prosthesis at the time of initial implant cannot be totally excluded based on the evidence collected during the investigation.After cleaning with sodium hypochlorite solution, the visual inspection was repeated and confirmed that the observed damage was caused by surgical tools.This was further verified and confirmed by the inspection carried out by means of stereomicroscope.Apart from the damaged areas, the visual inspection revealed no anomalies or manufacturing defects.In order to attempt to reproduce the reported event, a hydrodynamic testing was conducted on the returned prosthesis cphv f7-031 ¿ sn (b)(6).While the test is usually performed on the functional body of the prosthesis (orifice + 2 leaflets) once the stiffening ring component has been removed, in this specific case, due to the presence of a heavily damaged orifice, it was decided not to remove the stiffening ring component to prevent the release of any residual tensions, which could have caused the complete fracture of the orifice and compromised the possibility of conducting the test.For this reason the test was conducted using a special silicone sample holder.In addition, the test was conducted by housing the prosthesis not in mitral, as its anatomical implant position, but rather in the aortic position.The purpose was to enable a better inspection of the outflow side during the test and to expose the prosthesis to a prolonged phase in the closed position (static phase of the test), allowing for a more thorough assessment of any potential regurgitation.In fact, the static phase during the test with the valve in the aortic position accounts for 65% of the total cycle, compared to 35% if tested in the mitral position.The hydrodynamic test 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.Specifically, at normotensive conditions (c.O.5.0 l/min and m.A.P.Of 100 mmhg) the regurgitant fraction (rf%) was 8.1% , which is below the minimum requirement of iso 5840 (rf% < 20.0%) for an equivalent valve size.The effective orifice area (eoa) was 2.59 cm2 , which is above the minimum requirement of iso 5840 (eoa > 1.95 cm2 ) for an equivalent valve size.Based on the analyses carried out it is possible to conclude that the reported event cannot be attributed to the quality of the returned valve, since no intrinsic anomalies were detected on the returned prosthesis and no mechanical malfunctions were detected or reproduced in our laboratories.

• 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: 21317651
• Report Number: 3005687633-2025-00098
• Device Sequence Number: 20973499
• Product Code: LWQ
• UDI-Device Identifier: 08022057012876
• UDI-Public: (01)08022057012876(240)F7-031(17)270927
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P900060S019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: CPHV
• Device Catalogue Number: F7-031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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 Sex: Male