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

Model Number	CPHV
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of a leaflet breakage occurred on (b)(6) 2025, while implanting a carbomedics optiform mitral mechanical valve f7-029.The damaged prosthesis was removed from the patient and replaced with another prosthesis of the same model and size.Reportedly the patient was not affected because of the event and the procedure was completed with a good patient's outcome.
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 to gather further information concerning the circumstances surrounding the event.A follow up report will be submitted upon receipt of any new information or at the completion of the investigation.
Event or Problem Description
The manufacturer was informed of a leaflet breakage occurred on (b)(6) 2025, while implanting a carbomedics optiform mitral mechanical valve f7-029.Reportedly, during a mitral valve replacement via full sternotomy, one of the valve's leaflets fractured following the parachuting maneuver and while the prosthesis was being sutured into place.It was also confirmed that a rotator was used to rotate the prosthesis.The damaged mechanical valve was removed from the patient and replaced with another prosthesis of the same model and size.As reported, the patient was not affected because of the event and the procedure was completed with a good patient's outcome.The broken prosthesis was returned to the manufacturer for investigation and it was received on 30 april 2025.
Additional Manufacturer Narrative
Updated sections: a2, a3a, b4, b5, g3, g6, h2, h3, h6, h11.Corrected fields: h6.The returned device was received inside its original plastic jar in dry conditions.The valve was found detached from the holder and with a fractured leaflet loose in the jar.The broken leaflet was visibly missing some fragments, though a small portion fit perfectly with the main piece.The suture ring appeared intact without damage and with some visible stitches.After formalin decontamination and hypochlorite treatment, the sewing cuff of the returned valve was removed to identify the serial number, and its position, allowing a correct traceability of the prosthesis and its components.The undamaged leaflet corresponds to the right leaflet, while the left leaflet was fractured at the level of the back ear, with signs of damages on the front ear.Examination of the fractured surface under varying magnifications revealed no harmful voids, inclusions, or other manufacturing or material-related defects that could have contributed to the leaflet's failure.Analysis of the fracture line indicated that the propagation began at the ear and extended toward the middle of the central edge.Microscope pictures of the back ear revealed damaged areas in two distinct positions.At one location, a scratched area was visible on the surface of a chipped section of pyrolytic carbon, while at the other location, the morphology exhibited scratch marks on an intact pyrolytic carbon surface.Detailed imaging of these areas was performed using a scanning electron microscope (sem), with additional analysis conducted via energy dispersive x-ray spectroscopy (eds).Imaging analysis confirmed that the fracture originated at the contact interface between the ears and the pivots.The fracture exhibited a morphology consistent with patterns documented in the literature and in cases associated with mishandling.Typically, such leaflet fractures result from excessive force applied to the outflow surface near the pivot, leading to brittle failure of the pyrolite carbon-coated leaflet.In this case, the fracture originating at the left back ear can be confidently attributed to over-rotation.The chipped area on the left front pivot also appears to result from pressure caused by over-rotation, although the damage in this region was less severe.The combined effects of over-rotation and torsional stress caused the left front ear to dislodge, leaving behind characteristic marks identified as 'escaping scratches.' it is reasonable to conclude that the failure of the leaflet (on the posterior side) and the pivot (on the anterior side) occurred almost simultaneously.In summary, based on the examination of the returned carbomedics prosthesis, it is possible to conclude that a load exceeding the ultimate strength of the pyrolytic carbon was inadvertently applied to the leaflet during handling of the device during implantation.This caused local overloading of the component, ultimately resulting in the leaflet's breakage and escape.It should be noted that the analysis of the manufacturing records, which included the review of the x-ray performed to exclude voids, flaws, and irregularities in the internal structure of the leaflet and the review of the proof function tests performed on the separate leaflets and on the valve assembly which are followed by dye liquid penetrant inspection with the aim to detect any possible component failures, confirmed that the involved prosthesis satisfied all material, dimensional and performance requirements at the time of manufacture and release.Furthermore, no manufacturing or material-related defects were identified in the returned prosthesis, thereby ruling out quality issues as a contributing factor in the leaflet failure.

• 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
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 22028436
• Report Number: 3005687633-2025-00113
• Device Sequence Number: 15481884
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)290504
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: F7-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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 Age: 56 YR
• Patient Sex: Male