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

Model Number 9355FS29

Device Problems Air Leak (1008); Hole In Material (1293)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

During the preparation of a novaflex+ delivery system the operator was unable to de-air the balloon.Upon inflating the delivery system balloon a small hole in the balloon was noted.A second delivery system was prepared without issue.Reportedly no tools were used to remove the balloon cover.

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Due to no product (or photo) being returned for evaluation, the reported balloon leakage was unable to be confirmed.Dhr review, complaint history analysis and manufacturing mitigations did not reveal any indications that a manufacturing nonconformance was the source of the complaint.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed and therefore, the root cause of the failure is unable to be determined.During manufacturing, the device undergoes multiple inspections including balloon verification performed during the pleat and fold.During this process, the balloon is inflated.It would not have been possible to inflate the balloon if the observed damage was present at this stage.There are no sharp tools used during the pleat, fold, and form process.At the end of the pleat, fold, and form process the balloon covers are installed to protect both the crimp and inflation balloons from damage.In addition the balloon is leak tested after the balloon cover is installed.The observed leakage would have been detected at this point and the presence of the balloon cover ensures that the balloon remains protected from damage after the leak test is completed.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

• 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: 4245560
• MDR Text Key: 4991149
• Report Number: 2015691-2014-02666
• 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
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2016
• Device Model Number: 9355FS29
• Device Lot Number: 59848698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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