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

Model Number 9600LDS26

Device Problems Inflation Problem (1310); Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2020

Event Type  Injury  

Event Description

During a tavr procedure, the insertion of the valve deployment device was successful, however upon deployment of the valve, the balloon only inflated partially.It also got caught up on the circular wire mesh of the device preventing its retraction and a subsequent valve deployment.While attempting to remove the device, the patient went into a lethal cardiac arrhythmia initiating a code blue, compressions were started and medications were given.The code lasted, approximately, 10-15 minutes before the normal rhythm returned.Afterwards, a successful transfemoral approach for valve placement was done, but the deployment device could not be removed from the subclavian artery.The balloon and valve tip remained in the patient since the ct surgeon decided to conclude the surgery due to the prolonged period of time, 4 hours, that the patient been under anesthesia.The patient was transported to icu afterwards.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10137405
• MDR Text Key: 194624038
• Report Number: 10137405
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS26
• Device Catalogue Number: 9600LDS26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 31390 DA