MAUDE Adverse Event Report: EDWARDS LIFESCIENCES NOVAFLEX+ DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9355FS26

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device was visually inspected for any defects at the balloon as well as along the catheter.No visual manufacturing abnormalities were observed.An attempt to prep the delivery system was made, but de-airing was unsuccessful, as continuous air bubbles were being introduced into the syringe.A gross leak was observed from a pin hole on the crimp balloon both during the reference air leak test and during the de-airing attempt.During dimensional analysis, the crimp balloon double wall thickness was measured at four different locations adjacent to the leak location.These measurements were found to meet specifications.A device history record (dhr) performed did not reveal any issues that could have contributed to the reported event.A lot history review revealed no similar complaints related to balloon/delivery system leakage.A review of complaint history revealed 3 similar returned complaints for balloon/delivery system leakage.These complaints were confirmed, but no manufacturing non-conformities were found on the returned samples.All balloons undergo multiple 100% inspections.These inspections support that it is unlikely that a manufacturing non-conformance was the source of the complaint.In this case, the reported balloon leakage was confirmed, but no indication of manufacturing non-conformance was identified in the returned device.The engineering evaluation was unable to determine the root cause of the complaint.No labeling or ifu inadequacies have been identified and review of complaint history did not reveal that occurrence rate exceeds the march 2015 control limits for this trend category.Therefore, no corrective or preventive action is required.

Event Description

The novaflex+ (nf+) delivery system was flushed and prepped per ifu.The nf+ balloon cover was manually removed with some difficulty.During nf+ device prep, a solid stream of bubbles was noted during negative pull back into the syringe.The wire lumen was re-flushed, and the de-airing process was done again.There was again a large amount of air noted coming back into the syringe.No bubbles were observed in the neutral position.Air and bubbles with fluid leaking were observed during positive position.During forward flush, air was noted coming out at the proximal portion of the nf+ balloon.A second delivery system was opened.There was no consequence to the patient.

Manufacturer Narrative

The delivery system was returned to edwards lifesciences for evaluation.During the preliminary inspection a gross leak was observed during leak test and a pinhole leak was observed at the balloon.Investigation of this event is ongoing, pending completion of the engineering evaluation.

• Brand Name: NOVAFLEX+ DELIVERY SYSTEM
• 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 4650499
• MDR Text Key: 19182390
• Report Number: 2015691-2015-00737
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2017
• Device Model Number: 9355FS26
• Device Lot Number: 59954432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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