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.
|
|
Search Alerts/Recalls
|
|