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

Model Number 9600LDS26J

Device Problems Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Exsanguination (1841); Hemorrhage/Bleeding (1888); Aortic Dissection (2491)

Event Date 02/27/2020

Event Type  Death  

Manufacturer Narrative

Per the instructions for use (ifu) cardiovascular injury, such as perforation or dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.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 be helpful in solving the problem.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause of the aortic dissection is unknown but is most likely related to patient anatomy and dilated ascending aorta along with device manipulation.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 by the edwards (b)(4) affiliate, during a tf tavr case with a 26mm sapien 3 the commander delivery system was gently manipulated in the vessel since the ascending aorta was enlarged at 50mm in diameter.The sapien 3 valve was deployed in the targeted position successfully and the procedure was completed.On the following day, the patient expired.Autopsy found a sharp ¿crack¿ on the ascending aorta at approximately 5cm above the aortic annulus.It was thought that a dissection generated from the crack and caused a hemorrhage.The cause of death was determined as bleeding from ascending aortic dissection.The operator mentioned it could not be denied that the delivery system damaged the ascending aorta during procedure.It was unknown why the dissection occurred on the following day.Aortic valve calcification was reported mild, and no calcification was observed on the aortic root to sinotubular junction.There was tortuosity above the renal artery.

Manufacturer Narrative

Reference capa-(b)(4).

• 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 (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: 9912647
• MDR Text Key: 186025915
• Report Number: 2015691-2020-11266
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: 9600LDS26J
• Device Lot Number: 62462926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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: 81 YR