MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; 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	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complete manufacturing and material records review for the cphv aortic mechanical valve model a5-021 (b)(6) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The manufacturer is following up with the site to retrieve additional information on the event and the device involved and will submit a follow-up report upon receipt of the device or of any further information.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023 a leaflet breakage was experienced while implanting a size 21 carbomedics standard aortic mechanical valve.Reportedly, the patient was not affected in consequence of the event.The manufacturer is following up with the site to retrieve additional information on the event and the device involved.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the carbomedics aortic mechanical valve, model a5-021, s/n (b)(6), as they pertain to the reported event, has been performed by the manufacturer's quality engineering.The results confirmed that the device satisfied all material, visual and performance standards required for a carbomedics model a5-021 valve at the time of manufacture and release, including: x-ray performed to exclude: voids, flaws, and irregularities in the internal structure of the leaflet; proof function tests performed on the separate leaflets and on the assembly.The device was returned to the manufacturer for evaluation and received with one leaflet correctly assembled while the leaflet affected by the breakage was missing.Images of the prosthesis, including the broken leaflet, had been shared with the manufacturer at the time of event notification.After decontamination and cleaning, the prosthesis was visual inspected by means of stereoscopic microscope.On the sewing cuff traces of suture stitches were found consistent with the normal implanting procedure, without detecting signs attributable to pre-existing defects.The serial number of the missing leaflet was identified and the corresponding x-ray images were retrieved and analyzed as part of the dhr review activity.Since the broken leaflet was not returned to the manufacturer, the only possible investigation that could be carried out was based on the comparison of the images received with those related to similar cases archived in corcym historical data base.Despite the not optimal quality of the pictures received, it was possible to identify some geometrical points of reference (i.E.Inflow / outflow side and or front / back side) and the appearance of the fracture starting point and progression direction.The fracture origin was clearly localized in correspondence to the contact area between the leaflet ears and pivots and showed a typical morphology that can be identified in similar cases documented in literature and in complaints related to device 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.The leaflet, subject to the excessive load, can break in two possible ways: along the axis joining the pivots; in a sloping direction towards the centerline edge.In the present case, the pictures received showed fracture lines of both types, resulting in the complete breakage of the structure.Even if a complete and exhaustive investigation was not possible since the leaflet affected by the breakage was not returned to the manufacturer, based of the analyses carried out and the comparison with the case studies documented in the literature and in corcym internal database, 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, causing local over loading of the component and finally resulting in the leaflet breakage and escaping.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023 a leaflet breakage was experienced while implanting a size 21 carbomedics standard aortic mechanical valve.Reportedly, the event occurred at the time of detaching the holder from the valve.No device malfunction was noted prior to the leaflet breakage.As reported, bypass and cross-clamp time were extended of approximately 40 minutes and patient was not affected in consequence of the event.The manufacturer was noified on (b)(6) 2023 that the patient passed away due to non device related causes (asphyxia due to food aspiration) on the 19th postoperative day, after being taken to the ward for follow-up,.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 17842170
• Report Number: 3005687633-2023-00123
• Device Sequence Number: 7095008
• Product Code: LWQ
• UDI-Device Identifier: 08022057012616
• UDI-Public: (01)08022057012616(240)A5-021(17)280416
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P900060
• 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): 11/09/2023

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: A5-021
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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 Sex: Female
• Patient Weight: 80 KG