MAUDE Adverse Event Report: CORCYM S.R.L. OPTIFORM PROSTHETIC MITRAL 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
Event or Problem Description
The manufacturer was informed of the following event.Before implanting the valve, sizing was performed (using corcym sizer) without any problem and optiform prosthetic mitral heart valve f7-025 was chosen to be implanted.The valve was tested without any issue being identified.After implanting the valve, it was detected by transesophageal echocardiography (tee) that the valve could not open/close.Reportedly, the valve could not move at all.As such, the valve was explanted.Using ecmo it had taken 100mins (40 mins for the normal situation); and replacing it with non-corcym valve size 25.Procedure was completed well, and the patient outcome was fine.Based on additional information received, almost total resection of the native valve was performed, but some chordae papillary muscle was kept.Reportedly, before closing the heart, the f7-025 valve was tested with valve detector and the result was good.After closing the heart, using echocardiographer, at the beginning (about 10 seconds), the valve functionality was okay, but suddenly the leaflet was blocked.Thus, the decision to replace it with a non-corcym valve.There were no abnormal patient geometries and no concomitant procedure was performed.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6.Corrected field: h1.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.The inspections performed on the returned valve confirmed the absence of manufacturing defects.The hydrodynamic testing was conducted on the cphv subassembly #29 of the valve f7-025 ¿ sn (b)(6) the valve showed a correct movement of the leaflets during opening and closing 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.Based on the performed analysis the reported event cannot be explained by any factor intrinsic in the involved device.The leaflet immobilization cannot be attributed to any abnormal features of the explanted prosthesis.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 or strands of chordal tissue, prosthesis size mismatch, suboptimal valve orientation, peculiar hydraulic conditions in the heart are indicated as possible cause for this event.

• Brand Name: OPTIFORM PROSTHETIC MITRAL 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: 15305769
• Report Number: 3005687633-2022-00133
• Device Sequence Number: 12052520
• Product Code: LWQ
• UDI-Device Identifier: 08022057012845
• UDI-Public: (01)08022057012845(240)F7-025(17)250908
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060/S019
• 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): 10/10/2022

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: 09/08/2025
• Device Model Number: CPHV
• Device Catalogue Number: F7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• 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: 08/05/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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