MAUDE Adverse Event Report: CORCYM S.R.L. 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	11/13/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Dhr review has been completed.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.Unknown disposition.
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a s5-023 valve was implanted on (b)(6) 2020 and the patient passed away.No further information is presently available.No indication of a device malfunction was received from the site regarding this event.
Additional Manufacturer Narrative
Updated sections a2, a3, b4, d3, g1, g3, g6, h1, h2, h6.Based on the available information, it is not possible to establish a definitive root cause on the reported event.However, per the document review performed, no manufacturing deficits were identified.The manufacturer has reached out to the hospital to retrieve additional information on this event but no further information has been received to date.As the manufacturer is unable to perform any additional investigation, the case is considered closed at this time.Should the manufacturer receive additional information at a later stage, the case will be re-opened and further actions will be taken as deemed applicable.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 11605743
• Report Number: 3005687633-2021-00108
• Device Sequence Number: 11797072
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)230204
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/24/2021

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: 02/04/2023
• Device Model Number: CPHV
• Device Catalogue Number: S5-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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: Death
• Patient Age: 53 YR