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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/01/2022

Event Type  Death  

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 4 2022 data extract for mitral death event for the sapien 3 ultra valve.This report summarizes 1 cardiac perforation death event for the sapien 3 ultra transcatheter heart valve.The age range for these events is 76 years.The breakdown for gender is as follows: 1 female.

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 1 cardiac perforation death event for the sapien 3 ultra transcatheter heart valve in the mitral position.The "time to event" (tte, in days) for this event was 0.0.The device identification (di) numbers for edwards commander delivery system are: (b)(4).Per the instructions for use, 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 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 product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.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 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.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16030711
• MDR Text Key: 305970103
• Report Number: 2015691-2022-09905
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: E2016006
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 76 YR