MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	S5-023
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Mitral Regurgitation (1964)
Date of Event	03/10/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the study publication 'summary report of clinical follow-up and statistical analysis of cphv-s5 prosthetic heart valve'.This study aims to evaluate the mid- and long-term safety of prosthetic heart valve after implantation through a retrospective follow-up analysis.A total of 300 patients were followed-up in this study.The results of this retrospective follow-up study showed that the cphv-s5 (carbomedics top hat) prosthetic heart valve has low incidences of related clinical events after implantation, with no occurrence of unexpected adverse events, thus has good mid- and long-term safety.Among the results presented in this study, one patient experienced a device dysfunction (perimitral leak, nhya class ii) leading to a reintervention.The device was implanted on (b)(6) 2013 and a re-operation (perimitral leak closure) was performed on (b)(6) 2014.The patient was reportedly well after the procedure.From the study publication, it is not confirmed/clear if the device was explanted as a result of the perivalvular regurgitation.
Event or Problem Description
The manufacturer was informed on this event through the study publication 'summary report of clinical follow-up and statistical analysis of cphv-s5 prosthetic heart valve'.This study aims to evaluate the mid- and long-term safety of prosthetic heart valve after implantation through a retrospective follow-up analysis.A total of 300 patients were followed-up in this study.The results of this retrospective follow-up study showed that the cphv-s5 (carbomedics top hat) prosthetic heart valve has low incidences of related clinical events after implantation, with no occurrence of unexpected adverse events, thus has good mid- and long-term safety.Among the results presented in this study, one patient experienced a device dysfunction (perimitral leak, specified as perivalvular leak, nhya class ii) leading to a reintervention.The top hat valve was implanted on (b)(6)2013 and a re-operation (perimitral leak closure) was performed on (b)(6)2014.The patient was reportedly well after the procedure.From the study, it is not confirmed if the top hat valve was explanted as a result of the perivalvular regurgitation.However, per additional information received, it was confirmed that the top hat was correctly implanted in aortic position and that the leak concerns the mitral valve.At the time of the top hat implant, the patient also received a mitral valve replacement with a competitor's valve.Despite the event is reported as 'valve-related' in the study, the relationship between the top hat valve and the mitral valve 'perimitral leak' has not been further specified.
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 available information, the reported event does not concern the top hat device, as the competitor's device implanted in mitral position is affected by the reported perivalvular leak.Despite the event has been reported in the study as 'valve-related', it is unclear at this time if the valve-relationship involved the livanova device.Furthermore, the re-operation performed (i.E perimitral leak closure) does not suggest that the top hat was explanted as a result of the reported event.Considering the available information, there is not sufficient evidence to suggest a device relationship between the reported event and the device.Should additional information be received, the manufacturer will re-assess the event and submit a follow-up report as applicable.

• 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, vercelli
• MDR Report Key: 9821956
• Report Number: 1718850-2020-01027
• Device Sequence Number: 1828012
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)170817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020
• Report Date (Section F): 02/13/2020

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: 08/17/2017
• Device Model Number: S5-023
• Device Catalogue Number: S5-023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2020
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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