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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS
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SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS Back to Search Results
Model Number S5-023
Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aortic Insufficiency (1715); Mitral Regurgitation (1964)
Event Date 03/10/2014
Event Type  Injury  
Manufacturer Narrative
Unknown disposition.
 
Event 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.
 
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.
 
Event 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.
 
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Brand Name
CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
Type of Device
MECHANICAL HEART VALVE PROSTHESIS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vercelli
MDR Report Key9821972
MDR Text Key191914482
Report Number3005687633-2020-00105
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier08022057012913
UDI-Public(01)08022057012913(240)S5-023(17)170817
Combination Product (y/n)N
PMA/PMN Number
P900060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/17/2017
Device Model NumberS5-023
Device Catalogue NumberS5-023
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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