MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS COMMANDER DELIVERY SYSTEM; CATHETER BALLOON

Model Number 9600LDS23

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Hypoxia (1918)

Event Date 10/12/2015

Event Type  Injury  

Event Description

Balloon ruptured during the valve deployment.Unable to remove the balloon through the delivery sheath resulting in vascular complication requiring vascular repair.Patient hypoxic; taken to hyperbaric chamber x1 one with full neurologic recovery.Return home.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: CATHETER BALLOON
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 5328990
• MDR Text Key: 34413324
• Report Number: 5328990
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Model Number: 9600LDS23
• Device Catalogue Number: 9600LDS23
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR