EDWARDS LIFESCIENCES LLC SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
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Model Number 9600TFX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pericardial Effusion (3271)
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Event Date 11/18/2021 |
Event Type
Death
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Manufacturer Narrative
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Per the device instructions for use (ifu) pericardial effusion/cardiac tamponade are potential adverse events associated with standard cardiac catheterization, balloon aortic valvuloplasty (bav) and tmvr procedures.Pericardial effusion is an abnormal accumulation of fluid in the pericardial cavity.Because of the limited amount of space in the pericardial cavity, this will lead to increased intra-pericardial pressure, which can negatively affect heart function.Pericardial effusion can be caused by a variety of local and systemic disorders, or may be idiopathic.It can be acute or chronic, and in thv patients, it may be caused by lv perforations, annular ruptures, aortic dissections or other cardiac injuries.In transapical patients, post operative pericardial effusions are common.Most will resolve spontaneously, and some may require an intervention.When there is a pericardial effusion with enough pressure to adversely affect heart function, this is called cardiac tamponade.Cardiac tamponade is a life threatening condition.Because of the limited amount of space in the pericardial cavity, fluid accumulation will lead to an increased intrapericardial pressure which can negatively affect heart function.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 ultra thv.Training includes device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.With the limited information the cause of the pericardial effusion is unknown but may be related to the factors listed above.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Event Description
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As reported from our affiliates in (b)(6), this was a case of a 23 mm sapien 3 transcatheter heart valve in mitral position by transfemoral approach in a pre-existing surgical valve.The patient passed away on pod 1 due to pericardial effusion.
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Manufacturer Narrative
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Per the device instructions for use (ifu) pericardial effusion/cardiac tamponade are potential adverse events associated with standard cardiac catheterization, balloon aortic valvuloplasty (bav) and tmvr procedures.Pericardial effusion is an abnormal accumulation of fluid in the pericardial cavity.Because of the limited amount of space in the pericardial cavity, this will lead to increased intra-pericardial pressure, which can negatively affect heart function.Pericardial effusion can be caused by a variety of local and systemic disorders, or may be idiopathic.It can be acute or chronic, and in thv patients, it may be caused by lv perforations, annular ruptures, aortic dissections or other cardiac injuries.In transapical patients, post operative pericardial effusions are common.Most will resolve spontaneously, and some may require an intervention.When there is a pericardial effusion with enough pressure to adversely affect heart function, this is called cardiac tamponade.Cardiac tamponade is a life threatening condition.Because of the limited amount of space in the pericardial cavity, fluid accumulation will lead to an increased intrapericardial pressure which can negatively affect heart function.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 ultra thv.Training includes device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.With the limited information the cause of the pericardial effusion is unknown but may be related to the factors listed above.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Event Description
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As reported from our affiliates in (b)(6), this was a case of a 23 mm sapien 3 transcatheter heart valve in mitral position by transfemoral approach in a pre-existing surgical valve.The patient passed away on pod 1 due to pericardial effusion.
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Manufacturer Narrative
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Updated d4 (serial number and expiration date) and h4.
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Search Alerts/Recalls
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