MAUDE Adverse Event Report: SORIN GROUP ITALIA 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 Codes	Aortic Valve Stenosis (1717); No Information (3190)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2010 a carbomedics top hat s5-023 mechanical aortic heart valve was implanted.On (b)(6) 2018 the valve was explanted due to severe aortic stenosis and replaced with a carbomedics s5-021 mechanical aortic heart valve.Patient condition is reported as doing well.
Additional Manufacturer Narrative
Upon review of the received information regarding the case the manufacturer has identified that no further investigations are possible based on the limited information.The device location is presently unknown and thus the device cannot be returned for analysis.The dhr review confirmed the device met all required standards at the time of manufacturer and release, however based on the limited information the root cause of the event cannot be established at this time.If further information is received regarding the adverse event the manufacturer will reassess the investigation.Fields changed.
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.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7401468
• Report Number: 3005687633-2018-00134
• Device Sequence Number: 1470252
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)AA08
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2018

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: Physician
• Device Expiration Date: 08/08/2022
• Device Model Number: CPHV
• Device Catalogue Number: S5-023
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 10/05/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 07/25/2018; 10/07/2018
• 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: 60 YR