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 Insufficient Information (4580)

Event Date 04/28/2023

Event Type  malfunction  

Event Description

The manufacturer was informed that on (b)(6) 2023, after sizing with corcym sizer, optiform mitral valve size 27 was implanted.Reportedly, the leaflet was stuck and difficult to open / close.As such, another optiform valve size 27 was implanted in the patient.Based on the further inforamtion received, while testing the leaflet with a tester after the suturing was completed, the blockage was detected.As reported, there was no abnormal geometry in patient's anatomy and no concomitant procedure was performed.Furthermore, no additional debridement or annular restructuring was performed prior to the second implant.Reportedly, 30 minutes was added to the procedure as a result of this event, and patient was stable through the prolongation of surgery with a good outcome.

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.Since the device was discarded at the hospital and was not returned to the manufacturer, further investigation on the device cannot be performed and definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.H3 other text : the valve was scrapped by site due to contamination.

• 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 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 17043905
• MDR Text Key: 316967178
• Report Number: 3005687633-2023-00117
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)270829
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/01/2023

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
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: F7-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Female