MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF29

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during a transfemoral tavr case with a 29mm commander delivery system, there was difficulty with aligning the valve within the balloon markers and it was ¿suspected¿ that the balloon was damaged.A new system was prepared and used.After pre-dilation this valve was successfully implanted with no further difficulties.

Manufacturer Narrative

Additional information was obtained through pre-deco engineering evaluation observation, the balloon was able to be fully inflated.In this case, the physicians were unable to align the valve within the balloon markers despite pulling ¿quite strongly¿.After difficulty to pull the balloon back within the stent frame, there was a suspicion that the balloon had become ¿damaged¿.A decision was made to remove the delivery system and insert a new system of the same size.The valve was successfully implanted.In addition, patient factors (pre-stented pulmonary position) most-likely contributed to the difficulty with aligning the valve within the balloon markers.Based on these results, this complaint is no longer considered to be reportable event and a corrected supplemental report is being submitted.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• MDR Report Key: 8182255
• MDR Text Key: 131332346
• Report Number: 2015691-2018-05448
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: 9610TF29
• Device Lot Number: 61550372
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 11/26/2018; 12/19/2018
• Supplement Dates FDA Received: 12/21/2018; 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1