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	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event.On (b)(6) 2023, carbomedics standard aortic heart valve size 21a (5-021) broke during the operation while placing it to the right anatomical position.Reportedly, there was no issue with the leaflets and there was no negative outcome on the patient.No further information is available at this time.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device 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 valve was returned to the manufacturer.After decontamination and cleaning the dislocated leaflet was unlocked allowing a complete visibility of all the surfaces of the orifice including the flat area and the hinges cavities.The dislocated leaflet appears in an unnatural position that is geometrically not consistent with the dimensions of the orifice.In fact, the orifice results also broken.Comparison of the returned device with the x-ray retrieved from the dhr, results that the broken leaflet corresponds to the left leaflet.The location of breakage is where the maximum tensile stress is applied to the leaflet in a condition when the leaflet is forced to over rotate in the opening direction.Such an over rotating force would likely occur by means of surgical instrumentation or it is the result of a mishandling of the valve with not dedicated accessories.The attached scheme shows the resulting load and contact areas based on the simulation and the effects detected.Then, following the breaking, the broken leaflet escaped from the hinge and from the orifice.A possible incorrect operation on a demo valve was reproduced.The leaflet, subjected to the described load, can fracture in two possible ways: along the axis joining the pivots; in a sloping direction towards the centerline edge.In the present case, the fracture occurred, in direction towards the center, according with the second of these failure modes.The visual inspection of the fracture surfaces confirmed the absence of any kind of material or manufacturing defects.On the other hand, the fracture observed on the orifice is reasonably associated to a handling with surgical tools (i.E., forceps or other surgical instrument) during an undeterminable phase that could be occurred simultaneously or in a second time.It is not possible to exclude even that it occurred during the removal procedure.The right leaflet, once forced, dislocated out of the hinge cavities and finally remained stuck in the position in which it was at the first examination.Regardless of the exact time frame, what was observed should not be considered the cause of the breakage that occurred on the left leaflet.Based on the analysis performed, it was confirmed that the returned carbomedics valve satisfied all material and dimensional requirements of a carbomedics standard - model a5-021, at the time of manufacture and release.The fracture surfaces are free from material irregularities, thus allowing a manufacturing defect to be ruled out as a possible cause or contributing factor to the reported event.The examination of the returned carbomedics valve led to the conclusion 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 and torque of the component and finally resulting in the leaflet breakage and escaping.
Event or Problem Description
The manufacturer was informed of the following event.As reported, on 13 feb 2023, carbomedics standard aortic heart valve size 21, a5-021 was broken during the operation while placing it to the right anatomical position.Reportedly, there was no issue with the leaflets and there was no negative outcome on the patient.Reportedly, there was no effect on the patient and patient was stable through the delay in the surgery.Based on the information received, no device failure has been recorded prior to this event, leaflets and were okay.Reportedly, it has come off the hinge.In order to prevent leakage into the ventricle, one of the leaflets was broken while it was being removed by grasping the leaflets.The main problem was in the hinge section.

• 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, 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: 16559736
• Report Number: 3005687633-2023-00103
• Device Sequence Number: 5729305
• Product Code: LWQ
• UDI-Device Identifier: 08022057012616
• UDI-Public: (01)08022057012616(240)A5-021(17)270927
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/15/2023
• 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