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

Model Number 9610TF29

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/10/2022

Event Type  Death  

Event Description

During a mitral valve-in- valve procedure via transeptal approach, during the deployment of the valve, the guidewire punctured the left ventricle creating an effusion in the pericardium.After pericardiocentesis, the patient expired.Attempts are being made for additional information.The patient demographics are unknown at this time.

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, and myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a thv 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.Per the instructions for use (ifu), cardiac perforation is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive as patient and procedural factors were not provided; however, the event could be related to the mechanisms described above.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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 monthly, 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 per medical opinion, the patient had been on dialysis for 10 years and the tissues were very fragile.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15915676
• MDR Text Key: 304804920
• Report Number: 2015691-2022-09663
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 64418494
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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): Death