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

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
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 device has been returned to the manufacturer and investigation on the device is ongoing.A follow up report will be provided upon compeletion of investigation and/or receipt of any further information.
Event or Problem Description
The manufacturer was informed on 28 aug 2024, after surgery, it was found through echo that one of the leaflets of optiform size 27 could not close and there was reflux.After reinstalling another valve of corcym, echo returned to normal.No further information is available.
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 device was returned to the manufacturer.After decontamination, a visual inspection was performed and trace of residue, with appearance of organic material / fresh thrombotic formations, was noticed in the hinge cavity.This residue is reasonably the cause of the reduced mobility observed on initial gross examination.The sewing cuff was then removed, and a cleaning was then carried out, and the orifice¿ serial number (b)(6) was identified.It is possible to see the functional body of the prothesis after the cleaning procedure, where the hinges cavities appeared clean and without foreign material, and finally the leaflets resulted freely moving.The visual inspection was carried out without noticing any manufacturing defects.The hydrodynamic testing conducted on the cphv subassembly #27 (b)(6) of the valve f7-027 ¿ sn (b)(6)-a was performed.The 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.The testing result at normotensive condition (c.O.5.0 l/min and m.A.P.Of 100 mmhg) are the following: ¿ the regurgitant fraction (rf%) is 6.6% and it is below the minimum requirement of iso 5840 (rf% < 15%) for an equivalent valve size.¿ the effective orifice area (eoa) is 2.39 cm2 and it is above the minimum requirement of iso 5840 (eoa > 1.70 cm2) for an equivalent valve size.Based on the information available, the definitive root cause of the event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Phenomena of partial leaflet immobilization, that could induce opening / closing difficulties, have been described in the clinical literature to several models of mechanical valves.Possible causes also include the presence of small formations of clots / thrombi consistent with the reported case history.In summary, manufacturer was not able to reproduce the any mechanical malfunction in the laboratories, it is possible to argue that the cause of reported event was not related to device.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino saluggia vercelli; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 20323123
• Report Number: 3005687633-2024-00117
• Device Sequence Number: 15399450
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)280410
• Combination Product (Y/N): N
• 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: 2024
• 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): 11/07/2024

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: F7-027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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: 37 YR
• Patient Sex: Male