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	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was informed that f7-029 valve was implanted in the patient on (b)(6)2023.Reportedly, the tee and echo images showed that one leaflet couldn't be closed, along with pvl.As such, the valve was explanted, and smaller valve (f7-027) was implanted to complete this procedure since no more f7-029 was available.After the procedure, the patient outcome is fine.Reportedly, no malfunction with the device was noted prior to this event.As reported, no sub-valvular apparatus was preserved, a debridement surgery was performed prior to the implant of second valve.Reportedly, before implanting the second valve (f7-027), the first valve(f7-029) was rotated several tens of angles, but there was still one leaf that was not closing.Furthermore, patient was stable through the prolongation of surgery.
Additional Manufacturer Narrative
The manufacturing and material records for the cphv heart valve, model #f7-029, s/n (b)(6), as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #f7-029) cphv heart valve at the time of manufacture and release.A follow up report will be provided upon receipt of the device or any further information.
Additional Manufacturer Narrative
The valve was returned to the manufacturer.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 f7-029 ¿ 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 leaflet's 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 (see attached pictures).The effective orifice area (eoa) at 70 bpm, c.O.Of 5.0 l/min and m.A.P.Of 100 mmhg is 3.30 cm2, above the iso 5840 minimum requirement 1.70 cm2; the regurgitant fraction (rf%), under the same testing conditions, is 6.7%, below the iso 5840 requirement of 15%.No anomalies were observed during the open/close cycle.Based on the analysis performed, no anomalies were noted, and the returned valve showed a normal behavior meeting the standards required for a carbomedics optiform f7-029.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 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 of the same model but smaller size, it is possible to consider the mis-sizing the most probable cause.

• 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, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby
• MDR Report Key: 17600151
• Report Number: 3005687633-2023-00122
• Device Sequence Number: 6263330
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)270927
• 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): 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: F7-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/19/2023
• 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: Unknown