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

Model Number 9610TF23

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported through our (b)(6) affiliate, during preparation of a commander delivery system, a hole in the balloon was noted.A new delivery system was used.

Manufacturer Narrative

The delivery system was returned to edwards lifesciences for evaluation.During visual inspection, a kink was present near the middle of the flex shaft (likely due to packaging), and a cut was present on the inflation balloon.No other visual abnormalities were observed on the balloon or the delivery system.Evaluation of the balloon cover for damage (similar tear, puncture, kink, etc.) was not possible, as the balloon cover was not returned for evaluation.Due to the condition of the return device (a cut in the inflation balloon), further functional testing was unable to be performed.Dimensional analysis of the balloon found the balloon wall thickness met specifications.A cut in the balloon was confirmed.Engineering is unable to determine the exact root cause of the complaint based on available information.The review of manufacturing mitigations indicated that it was unlikely that a cut was present during manufacturing as devices are 100% leak tested and visually inspected for defects, including holes and leaks.In addition, all devices are checked for proximal balloon cover splits during balloon cover placement.The damage to the balloon was observed during device preparation and was not noted out of box.In this case, it is possible that excessive handling during prep of the device at the site caused damage to the balloon, which led to the observed leak.Other procedural factors such as removal of the proximal balloon cover and handling the stylet or handling other tools in close proximity may produce this type of damage.No manufacturing non-conformances were identified in the product evaluation, and no labeling/ifu deficiencies were identified.A review of complaint history revealed that the occurrence rate does not exceed the may 2016 control limits for these trend categories.Therefore no preventative or corrective actions are required.

• 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: 5703674
• MDR Text Key: 46717281
• Report Number: 2015691-2016-01832
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2018
• Device Model Number: 9610TF23
• Device Lot Number: 60361610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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