MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material records review for the carbomedics reduced mechanical valve, model #r5-023 s/n (b)(6), was 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 further information regarding this event and the device involved.A follow up report will be provided upon receipt of the device or of any further information.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023 a patient underwent aortic valve replacement with carbomedics reduced size 23 mechanical prosthesis and replacement of the ascending aorta for the treatment of aortic stenosis and dilatation of the aorta.Patient's native aortic valve was bicuspid.As reported, while applying traction on the mechanical prosthesis to add a suture at the end of the procedure, a breaking of one of the leaflets occurred which required the procedure to be repeated with a new prosthesis.Another carbomedics reduced valve was chosen as replacement device.While restoring cardiac function, the patient experienced recurrent ventricular fibrillation which required infusion of cordarone 300 mg and magnesium 2 g, resumption of bypass surgery and a new cardioplegia.Finally, cardiac function was successfully restored with external pacing and noradrenaline 2mg/h.Reportedly, the patient experienced fragility of the native annulus, conductive disorders (bav iii with escape rhythm at 50 bpm) and clamping time prolongation (cec time 146 min/aortic clamp time 120 min).Due to persistence of the conduction disturbance post-operatively (bav iii degree with afib) the patient underwent dual chamber pacemaker implant on (b)(6) 2023.
Additional Manufacturer Narrative
The manufacturer attempted to follow up with the site, but no further information was provided despite manufacturer's multiple attempts.The device was returned to the manufacturer.After decontamination and cleaning the broken leaflet was visually inspected by means of stereoscopic microscope.The broken leaflet presented two fracture origins in correspondence of the front and back ear with symmetrical paths toward the middle of the central edge and along a line substantially aligned to the pivots¿ axis.The fracture in the front ear resulted in a complete breakage of the structure, while in the back ear the fracture lines involved only the external shell of pyrolite carbon coating.Examination of the fracture surfaces at varying magnifications revealed them to be free from harmful voids, inclusions, or other manufacturing/ material related defects, which would have contributed to the leaflet breakage.The fracture origin is localized in correspondence to the contact area between the ears and pivots and it has a typical morphology that can be identified in similar cases documented in literature and in complaints 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.In these cases, the cracks start from the fracture origins located in correspondence to the maximum stress areas on the ears of the leaflet when it is subject to a load (i.E.Compression and traction depending if in the outflow or inflow surface) caused by over-rotation.The leaflet, subject to the described 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, both types of fracture lines were present resulting in the complete breakage of the structure.Based on the analysis performed, it is possible to conclude that the valve object of this complaint satisfied all the specifications.The review of the data contained in the device history record, including the x-ray performed at the time of manufacture and release to exclude voids, flaws, and irregularities in the internal structure of the leaflet and the proof function tests performed on the separate leaflets and on the assembly, confirmed that the returned carbomedics valve satisfied all material and dimensional requirements of a carbomedics reduced - model r5-023, at the time of manufacture and release.The analysis performed on the returned prosthesis has allowed to identify the root cause of the reported event, which is attributable to a load, exceeding the ultimate strength of the pyrolitic carbon, inadvertently applied to the leaflet while handling the device during the implant procedure, causing local over loading of the component and ultimately resulting in the leaflet breakage and escape.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• 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: 17314743
• Report Number: 3005687633-2023-00118
• Device Sequence Number: 11776658
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)280224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: R5-023
• Device Catalogue Number: R5-023
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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 Age: 42 YR
• Patient Sex: Female