MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF26U

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

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 10/25/2022

Event Type  Death  

Event Description

As reported from our affiliates in the netherlands, this was a case of a 26mm sapien 3 transcatheter heart valve in aortic position by transfemoral approach.During valve alignment, the guidewire came out of the ventricle.It was attempted to re-cross the native valve with many different wires, but it failed.Maximum flex was applied but without success.Finally, it was decided to abort the procedure.The valve was retrieved back into the esheath and removed it all together.After this was done, the patient had no blood pressure.Pericardial fluid was seen with transesophageal echocardiogram.There was immediate conversion to surgery and left ventricular perforation was confirmed.The lv was repaired, and a new valve was placed with a new system through direct aortic procedure.The valve was placed with good result and no paravalvular leak.The patient did not stabilize and eventually needed an ecmo and went to the icu.Later on, patient was in the ic and it was attempted to wean off ecmo.There was no allegation that any edwards device contributed to the wire loss or malfunctioned.

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries, including perforation or dissection of vessels, ventricle, myocardium or valvular structures, are potential adverse events associated with standard cardiac catheterization, balloon valvuloplasty and the transcatheter aortic valve replacement (tavr) procedure.There are several potential etiologies for ventricular perforation during a tavr procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.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 event 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 the netherlands, this was a case of a 26mm sapien 3 transcatheter heart valve in aortic position by transfemoral approach.During valve alignment, the guidewire came out of the ventricle.It was attempted to re-cross the native valve with many different wires, but it failed.Maximum flex was applied but without success.Finally, it was decided to abort the procedure.The valve was retrieved back into the esheath and removed it all together.After this was done, the patient had no blood pressure.Pericardial fluid was seen with transesophageal echocardiogram.There was immediate conversion to surgery and left ventricular perforation was confirmed.The lv was repaired, and a new valve was placed with a new system through direct aortic procedure.The valve was placed with good result and no paravalvular leak.The patient did not stabilize and eventually needed an ecmo and went to the icu.Later on, patient was in the ic and it was attempted to wean off ecmo.As per follow up received, the patient died.There was no allegation that any edwards device contributed to the wire loss or malfunctioned.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15801736
• MDR Text Key: 303703638
• Report Number: 2015691-2022-09267
• Device Sequence Number: 1
• Product Code: NPT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 64128468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• Date Device Manufactured: 01/31/2022
• 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): Required Intervention; Death
• Patient Sex: Male