MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 11/18/2021

Event Type  Death  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

Updated d4 (serial number and expiration date) and h4.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13580970
• MDR Text Key: 285965355
• Report Number: 2015691-2022-04088
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 9600TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death