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

Model Number 9600LDS29

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During valve deployment of a 29mm sapien 3 valve the balloon on the commander delivery system did not completely inflate.As reported, a 29mm commander delivery system minus 1cc was prepped.There was no obvious issues or problems observed during the device preparation.However, the atrion syringe was emptied during deployment, the balloon on the commander delivery system did not fully inflate (about 2/3 inflated).The team then immediately added additional contrast to the syringe in an attempt to fully inflate the balloon but was unsuccessful.Despite the balloon not being fully inflated, the sapien 3 valve was stable the entire time.A decision was made to prep another 29mm commander delivery system minus 1cc.The delivery system was positioned for post dilation.Post dilation resulted with expansion of the valve.There was no paravalvular (pvl) or central aortic insufficiency (cai).The patient was stable throughout the procedure.

Manufacturer Narrative

The delivery system was returned to edwards for evaluation.During visual inspection, a separation of the balloon shaft near the y-connector was observed.A kink was observed on the strain relief, crimped balloon and on the guidewire lumen, possibly due to shipping back from the site.No other abnormalities were observed.The delivery system dimensional and all balloon shaft measurements were found to be within specification.Functional testing revealed a leak during balloon inflation as fluid was observed to leak from underneath the balloon shaft strain relief.Upon removal of the strain relief, a break in the balloon shaft was found.The complaint for delivery system leakage was confirmed.Although it is possible that the balloon shaft was bent, kinked, or pulled during the procedure to cause or propagate the observed damage, it is also possible that something occurred in the manufacturing process which may have also contributed to the break in the shaft.Since the root cause is undetermined, a corrective action investigation has been opened to continue investigation and implement any needed corrective actions.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warning, contraindications, and the directions/conditions for the successful use of the device.

• 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 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: 5307444
• MDR Text Key: 33796323
• Report Number: 2015691-2015-03425
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2017
• Device Model Number: 9600LDS29
• Device Lot Number: 60195378
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2015
• 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
• Patient Age: 90 YR