MAUDE Adverse Event Report: CORCYM CANADA SRL CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown disposition.
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information received on the patient implant form, on (b)(6) 2020 a top hat size 27 was implanted into the patient.On (b)(6) 2021 the top hat size 27 was removed and a top hat size 25 was implanted.No allegation of a device malfunction or serious injury was received from the site regarding this event.
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 is not available for return, no further investigation can be performed.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified.Should further information be provided a follow up report will be sent.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM CANADA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 12287762
• Report Number: 3005687633-2021-00149
• Device Sequence Number: 3165030
• Product Code: LWQ
• UDI-Device Identifier: 08022057012937
• UDI-Public: (01)08022057012937(240)S5-027(17)231111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 11/11/2023
• Device Model Number: CPHV
• Device Catalogue Number: S5-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR