MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown device disposition.
Event or Problem Description
The manufacturer was informed of this event through patient tracking.The top hat suppraanular valve size 19, which was implanted on (b)(6) 2013, was explanted on (b)(6) 2020 due to severe aortic stenosis and valvular disease.The st.Jude 21mm valve was implanted in the patient instead.No further information is presently available.
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.Based on the information available, the definitive root cause of this event cannot be established.However, from the document review performed, no manufacturing deficiencies were identified.Manufacturer attempted to follow up with the hospital but no further information related to corcym's valve has been received.There is no evidence of the malfunction nor serious injury regarding the corcym's device.Should further information be received in the future, the manufacturer will provide a follow up report.
Additional Manufacturer Narrative
The device name, model, udi number has been corrected.Since no further information regarding this case has been received despite of multiple follow ups, the conclusion will remain the same.
Event or Problem Description
The carbomedics reduced aortic valve size 19, which was implanted on (b)(6) 2013, was explanted on (b)(6) 2020 due to severe aortic stenosis and valvular disease.The st.Jude 21mm valve was implanted in the patient instead.No further information is presently available.

• Brand Name: CARBOMEDICS REDUCED AORTIC 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: 13772403
• Report Number: 3005687633-2022-00110
• Device Sequence Number: 5063521
• Product Code: LWQ
• UDI-Device Identifier: 08022057012760
• UDI-Public: (01)08022057012760(240)R5-019(17)151219
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• 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): 05/18/2022

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: 12/19/2015
• Device Model Number: R5-019
• Device Catalogue Number: R5-019
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 04/01/2022; 05/10/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/28/2022; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2011
• 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: 47 YR
• Patient Sex: Female