MAUDE Adverse Event Report: CORCYM S.R.L. OPTIFORM PROSTHETIC MITRAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

The manufacturer was informed of the following event.Before implanting, the sizing was performed (using corcym sizer) with no problem and optiform prosthetic mitral heart valve f7-027 was chosen to be implanted.The valve was tested and no problem was identified.After implanting the valve, it was detected that the opening/closing of the valve leaflet was not smooth.As such, the valve was explanted and another f7-027 was planted.Reportedly, the procedure was completed well, and the patient outcome is fine.Based on the information received, almost total resection of the native valve was performed, but some chordae papillary muscle were kept.Reportedly, there was no abnormal patient geometries and no concomitant procedure was performed.

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.The inspections performed on the returned valve confirmed the absence of manufacturing defects.The hydrodynamic testing on the cphv subassembly #27 of the valve f7-027 ¿ sn (b)(6) was performed.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.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
• Type of Device: 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: 15306951
• MDR Text Key: 298762452
• Report Number: 3005687633-2022-00134
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)261029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060/S019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: F7-027
• 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
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention