MAUDE Adverse Event Report: CORCYM S.R.L. OPTIFORM PROSTHETIC MITRAL HEART VALVE; 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	01/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to the manufacturer.
Event or Problem Description
On (b)(6) 2021, an optiform size 23 mitral valve was implanted.Based on the information received, the valve leaflet broke while the surgeon were rotating the valve.The total duration of the surgery was more than 3 hours.The patient was stable during the procedure and is recovering.No device malfunction were detected prior to the event.As reported, the valve was rotated with the valve rotator provided by the manufacturer.
Additional Manufacturer Narrative
Fields updated: a2, b4.The age of the patient has been added to this report in section a2.
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.Since the device was not returned to the manufacturer for further investigation, a definite root cause of this event cannot be established.However, review of the manufacturing and material records for the device confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Should any further information be received, the manufacturer will update the reporting activity as applicable.

• 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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13515575
• Report Number: 3005687633-2022-00099
• Device Sequence Number: 4385186
• Product Code: LWQ
• UDI-Device Identifier: 08022057012838
• UDI-Public: (01)08022057012838(240)F7-023(17)221008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/22/2022

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: 10/08/2022
• Device Model Number: CPHV
• Device Catalogue Number: F7-023
• Was Device Available for Evaluation?: No
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 01/17/2022; 02/25/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 02/14/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female