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

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
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.Device received on 30 aug 2022, and investigation is on-going.A follow up report will be provided upon completion of investigation.
Event or Problem Description
The manufacturer was informed of implant and explant of carbomedics top hat mechanical heart valve , s5-021 that occurred on (b)(6) 2022.Based on the information provided, pre-operation, sizing was performed and it was okay, the product was also fine.However intra-operation, the leaflet was detected to be stuck.The valve was then replaced with another valve but same model (s5-021).Reportedly, patient was stable through and after the procedure.Based on further information received, no malfunction with the device was noted before the procedure and testing of the valve was okay.
Additional Manufacturer Narrative
The device was returned to the manufacturer.The inspections performed on the returned valve confirmed the absence of manufacturing defects.After the formalin treatment the leaflets were unlocked showing the dried blood presence along all the contact areas between leaflets and orifice, including inside the hinges cavities.After further cleaning and hypochlorite treatment the inspections performed on the returned valve confirmed the absence of manufacturing defects.The leaflets showed freely moving behavior.The sewing cuff was then removed.The serial number etched on the orifice is congruent with the one indicated from the field (i.E.Subassembly (b)(4)).The hydrodynamic testing on the cphv subassembly #21 of the valve s5-021 ¿ sn (b)(6) was also performed.The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in hypotensive and in normotensive conditions.The subject prosthesis was characterized by regular mechanical, kinematic and hydrodynamic behavior as determined by means of hydrodynamic tests performed on the returned valve.The leaflet immobilization cannot be attributed to any abnormal features of the explanted prosthesis.Based on the performed analysis the reported event cannot be explained by any factor intrinsic in the involved device.Phenomena of partial leaflet immobilization, that could induce an opening / closing difficulty, occurring to several models of mechanical valves, have been described in the clinical literature.Entrapment between the leaflets and the housing of unraveled sutures, long suture ends, prosthesis size mismatch, suboptimal valve orientation, peculiar hydraulic conditions in the heart are indicated as possible cause for this event.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART 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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15412233
• Report Number: 3005687633-2022-00138
• Device Sequence Number: 5640425
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)S5-021(17)250831
• 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: 2022
• Device Explanted Year: 2022
• 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): 09/26/2022

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 Expiration Date: 08/31/2025
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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