MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF23

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

The commander delivery system was returned for evaluation.Visual inspection was performed for defects at the balloon and y-connector area, and along the catheter.A slight bend/kink was observed at the proximal end of the balloon shaft near the strain relief.During the initial evaluation and after a 2-week air dry, the device was able to be successfully de-aired.No air bubbles were introduced into the system while drawing negative pressure.A red dye test was then performed by inflating the balloon with red dye to observe the leak path along the balloon catheter.Upon removal of the y-connector strain relief a hole/break in the balloon shaft was observed.A leak was observed originating from the balloon shaft to the y-connector bond area.Also noted was stretching of the balloon shaft material at this bond.A manufacturing defect was confirmed on the returned sample; however, no ifu/training inadequacies were identified.A review of complaint history from (b)(6) 2014 to (b)(6) 2015 revealed other returned complaints for commander delivery systems with leakage distal to the y-connector.The complaint for unable to de-air and delivery system leakage was confirmed, but no labeling inadequacies were identified.Although the complaint for unable to de-air was confirmed during functional testing, it is likely that the prepping difficulty was attributed to the balloon shaft break/crack under the strain relief.A risk assessment has been initiated to assess risks associated with the issue of balloon shaft fracture near the y-connector.Corrective and preventative actions are being addressed through a capa to further reduce the reoccurrence of the issue.Method: actual device evaluated: (b)(4); use testing: (b)(4); manufacturing review: (b)(4); result: manufacturing process problem: (b)(4)conclusion: operational context caused or contributed to event: (b)(4).

Event Description

As reported through our (b)(4) affiliate, during preparation for a transfemoral tavr procedure, the delivery system was unable to be de-aired.As reported, when de-airing the balloon, a lot of air was noted.The guidewire lumen was flushed prior to use.A second delivery system was used.During product evaluation, the device was unable to be de-aired and a balloon shaft crack was observed under the strain relief, distal to the y-connector bond.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 23MM
• 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: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5232976
• MDR Text Key: 31576570
• Report Number: 2015691-2015-03133
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: 9610TF23
• Device Lot Number: 60050956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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