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

Model Number	9600LDS26
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During post-placement dilation of transcatheter aortic valve replacement, the tavr deployment system balloon was overinflated to improve expansion of the heart valve and the balloon ruptured.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA 92614
• MDR Report Key: 6587300
• Report Number: MW5069996
• Device Sequence Number: 10913194
• Product Code: NPT
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 9600LDS26
• Device Lot Number: 60778393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 96