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

Model Number 9610TF23

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

Patient Problems Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 01/12/2023

Event Type  Injury  

Event Description

As reported by our edwards affiliate in china, a 23mm sapien 3 valve was implanted in the bicuspid valve in the aortic position via the transfemoral approach.Following balloon aortic valvuloplasty (bav), as the commander delivery system was crossing the native aortic valve, echo showed a severe pericardial effusion.The patient hemodynamics became unstable, and the patient was placed on a heart-lung machine.Open surgery was performed to repair the apical perforation caused by the guidewire.The sapien 3 valve was then successfully deployed in a final 90:10 aortic/ventricular (a/v) position.Post valve deployment, the hemodynamics were stable and no paravalvular leak (pvl) was observed.Upon removal of the delivery system, echo indicated an ascending aortic dissection.The ascending aorta was opened, and an artificial vessel replacement was performed.The patient was sent to the icu on mechanical support for monitoring.The valve remains implanted in the patient.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation as there were no allegations of a device malfunction.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, 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.Difficulty crossing the native valve may be due to anatomical and/or procedural factors, including heavy calcification, wire bias into commissure, horizontal aorta (tf), tortuous thoracic aorta, flex catheter kinked, skipped or incomplete bav, and/or interaction with other cardiac structures (e.G.Mitral valve entanglement during ta approach).In most instances this resolves with routine troubleshooting maneuvers, with minimal risk to the patient.Per the training manual, factors that can make it difficult to cross include "heavy calcification" and "inadequate bav''.Ascending aortic dissection may occur when multiple attempts are made to cross the stenotic native valve, and/or when excessive force is used.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).The thv training manuals provide guidance to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torquing of the flex catheter may help solve the problem.Per the instructions for use (ifu), cardiac perforation and ascending aortic dissection potential adverse events 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 suggest in addition to the procedure itself, patient factors (female gender, bicuspid aortic valve, horizontal aorta, severe aortic stenosis) may have caused or contributed to this event.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.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS 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: 16214718
• MDR Text Key: 307789499
• Report Number: 2015691-2023-10270
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9610TF23
• Device Lot Number: 64284551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female