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 Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During a transfemoral procedure, upon implanting the valve, the inflation stopped at 70% and a leak was observed in the hub of the system.There were attempts to use a syringe and plug the hole in order to fully inflate the valve.A second delivery system was prepared and the valve was fully dilated.Per report, there was a pin hole is the hub of the system.

Manufacturer Narrative

The delivery system was returned to edwards for evaluation.Visual inspection revealed a kink in the balloon shaft underneath the balloon shaft strain relief.Upon removal of the strain relief, a break in the balloon shaft near the y-connector, and a kink on the guidewire lumen at the distal tip was discovered.The cause was most likely due to handling of the device after the procedure as no issues of guidewire shaft kinks or resistance were reported).No other abnormalities were observed.Functional testing revealed a leak that was confirmed during balloon inflation as fluid was observed from underneath the balloon shaft strain relief.Dimensional testing of the balloon shaft outer diameter (od) was measured and was found to be within specifications.During the manufacturing process, the commander delivery system undergoes multiple inspections for mechanical damage, bonding processes, and balloon defects.All manufacturing lots undergo product verification testing on a sampling plan which includes a tensile test of the y-connector/balloon shaft joint.The complaint was confirmed; however, no labeling inadequacies were identified.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 the event occurred in the manufacturing process which may have also contributed to the break in the shaft.The root cause has not been determined at this time.A risk assessment and corrective (or preventative) actions are being addressed through a capa.Method: actual device evaluated; manufacturing review.Result: operational context caused or contributed to event.Conclusion: inconclusive-investigation in progress.

Manufacturer Narrative

(b)(4).

• 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: 5138329
• MDR Text Key: 27906288
• Report Number: 2015691-2015-02665
• 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
• Type of Report: Followup,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2017
• Device Model Number: 9600LDS29
• Device Lot Number: 60143687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• 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