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

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A follow up report will be provided upon completion of device investigation or receipt of additional information.H3 other text : investigation on the device is ongoing but has not yet been completed.
Event or Problem Description
The manufacturer was informed of the following event.On (b)(6) 2023, when implanting optiform prosthetic heart valve (f7-027), one leaflet was stuck and couldn't be opened.As such, the valve was explanted and another f7-027 was implanted in the patient to complete this procedure.Reportedly, patient was fine and stable.The test on the explanted valve was performed after explant and the leaflet had a stuck issue.Based on the further information received, thoracic surgery was performed to preserve the subvalvular structure.The subvalvular structure was observed and did not affect valve opening and closing, and the valve was also rotated.Reportedly, no additional debridement or reconstruction was performed before implanting the new valve.
Additional Manufacturer Narrative
Valve was returned to the manufacturer for further investigation.After decontamination and cleaning a visual inspection was carried out without notice manufacturing defects.The sewing cuff was then removed, in order to identify the serial number, and its position, allowing a correct traceability of the valve and its components.The hydrodynamic testing was conducted on the cphv subassembly #29 of the valve f7-027 ¿ sn (b)(6).Since the target of the test was to evaluate the kinematic of the valve, it has been tested in aortic position, in order to have a better visibility of the leaflets movement.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.Based on the analysis performed, the definitive root cause of the event cannot be established since no mechanical malfunction could be reproduced in our laboratories.Furthermore, from the document review performed, no manufacturing deficiencies were identified.Phenomena of partial leaflet immobilization, that could induce opening difficulty, have been described in the clinical literature to several models of mechanical valves.Possible causes from literature are entrapment between the leaflets and the housing of long suture tails, prosthesis size mismatch, suboptimal valve orientation and peculiar hydraulic conditions in the heart.For this specific case, considering that the valve finally implanted was the same model and size, it is possible to exclude the mis-sizing.Nevertheless, it is not possible to totally exclude that the conservative approach: ¿to preserve the sub-valvular structure¿ could have been the cause of leaflet entrapment and of the reported blocking behavior of the leaflet.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16892365
• Report Number: 3005687633-2023-00112
• Device Sequence Number: 6837316
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)270306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060/S019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/06/2023

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: 04/19/2023
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: Unknown