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

Model Number	CPHV
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer was informed that on (b)(6) 2024, a carbomedics optiform valve size 29 was planned to be implanted.Reportedly, while removing the holder and preparing the valve for implant, it was noted that the valve has only one leaflet.No further information is available at this time.
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.After decontamination and hypochlorite treatment the prosthesis was visual inspected by means of stereoscopic microscope.In the flat area near to the missing leaflet, some scratches were noticed and documented.The dhr of the carbomedics optiform valve sn (b)(6) was retrieved and reviewed, confirming that the valve in object satisfied all material and performance requirements of carbomedics optiform f7-029 at the time of manufacture and release, including: ¿ x-ray performed to exclude: voids, flaws, and irregularities in the internal structure of the leaflet.The missing leaflet is the one in the left position.It follows that it appears to be leaflet sn (b)(6).X-ray films of the leaflet in two different positions/views (i.E.Planar and cross-sectional view) were retrieved and re-inspected without revealing any abnormalities.¿ proof function tests performed on the separate leaflets and on the assembly.These tests are followed by dye liquid penetrant inspection with the aim to determine component failures.Based on the analyses carried out on the returned valve and on the manufacturer¿s experience on similar cases, it can be stated that the missing leaflet came out of its seat due to breakage.By virtue of the mechanical characteristics and the geometry of the coupling between leaflet and pivot in a cphv valve, the release of a leaflet cannot occur solely due to elastic deformation, but it can only happen following a geometric alteration of the structures (ears and pivots) responsible for hinging the two components (leaflet and orifice).Given the nature of the pyrolytic carbon material, the aforementioned geometric alteration cannot occur without a fracture in one or both components (leaflet and orifice), depending on the stress they are subjected.It is not possible to perform a detailed and exhaustive analysis since the leaflet which was declared missing was not traced and therefore was not made available for investigation.However, the traces detected in the flat area near the pivot are clear evidence that the leaflet fractured and escaped on that side.The fracture origin is localized in correspondence to the contact area between the ears and pivots producing typical morphologies that can be identified in similar cases documented in literature and in former complaints investigated by the manufacturer related to mishandling.In general, the fractured leaflet fails due to an excessive force applied to the outflow surface near the pivot, resulting in brittle fracture of the pyrolite carbon coated leaflet.Based on the dhr review performed, no manufacturing deficiencies were noted.Since the missing leaflet was not retrieved and returned, an exhaustive analysis could not be performed on the returned device.Nevertheless, based on the analyses carried, the identified evidence, the literature, and the similar cases analyzed in the past by the manufacturer, it is possible to conclude that a load, exceeding the ultimate strength of the pyrolytic carbon, was inadvertently applied to the leaflet during the handling of the device for implantation, causing local over-loading of the component and finally resulting in the leaflet breakage and escaping.
Event or Problem Description
Manufacturer was informed that on 5 july 2024, a carbomedics optiform valve size 29 was planned to be implanted.Reportedly, while removing the holder and preparing the valve for implant, it was noted that the valve has only one leaflet.Based on the further information received, after connected the suture with sewing cuff, the suture lock was cut and that is when the missing leaflet was noted.As such, the valve was removed and another carbomedics optiform f7-029 was implanted instead.Device box was checked, but no leaflet was found.No further information is available.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L; via crescentino sn; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L; via crescentino sn; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 19902568
• Report Number: 3005687633-2024-00114
• Device Sequence Number: 6556651
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)290204
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: F7-029
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/04/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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