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

Model Number R5-019

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 330932098
• Report Number: 3005687633-2023-00130
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012760
• UDI-Public: (01)08022057012760(240)R5-019(17)270314
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900060
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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