MAUDE Adverse Event Report: CORCYM CANADA CORP. CARBOMEDICS REDUCED AORTIC HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-019
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material records review for the cphv valve r5-019 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 limited information is available, the definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Based on the information available, r5-019 was replaced with a larger valve r5-023.As such, the cause of the reported event can reasonably be related to mis-sizing.Should further information be received in the future, a follow up report will be provided.H3 other text: not available for return.
Event or Problem Description
On (b)(6) 2023, a carbomedics reduced aortic valve r5-019 was implanted in a patient.As reported, the "condition was not good", so the valve was explanted and replaced with a larger valve r5-023 during the same day.The patient is doing well.Based on the further information received, the patient got better and has no problem anymore.The manufacturer was informed that no further information will be provided.

• Brand Name: CARBOMEDICS REDUCED AORTIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18361299
• Report Number: 3005687633-2023-00130
• Device Sequence Number: 7912545
• Product Code: LWQ
• UDI-Device Identifier: 08022057012760
• UDI-Public: (01)08022057012760(240)R5-019(17)270314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: R5-019
• Device Catalogue Number: R5-019
• 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: 11/21/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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