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

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

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

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint device [commander delivery system, model 9610tf29 lot number 60067165 is not sold or marketed in the us; however, it is deemed similar to the commercially available commander delivery system models [9600lds20, 9600lds23, 9600lds26, and 9600lds29].The delivery system will been returned for evaluation.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.

Event Description

It was reported by our european affiliate that a 29mm commander delivery system could not be de-aired properly during preparation.There was small hole observed in the delivery system balloon.A second commander delivery system was prepared and used.

Manufacturer Narrative

The delivery system was returned to edwards lifesciences for evaluation.The following was observed upon visual inspection: a pin hole was confirmed on the crimp balloon, proximal to the most proximal marker band.There were no other scratches on the crimp balloon or inflation balloon.No other visual abnormalities were observed.No applicable dimensional inspection could be performed due to the nature of the failure mode (mechanical damage / balloon leakage).During functional testing a leak was observed at the crimp balloon component while de-airing the device.The device could not be de-aired successfully.The reported leakage was confirmed, but no manufacturing non-conformities were found in the returned sample.There is insufficient information to determine root cause.However, it is unlikely that the delivery system left the manufacturing site with a pin hole on the balloon, as all devices are 100% leak tested.Per report: ¿no tools were used to remove the balloon cover.¿ it is possible, that the crimp balloon was damaged during the removal of the proximal balloon cover, handling the stylet or handling other tools in close proximity.At this time, a definite root cause could not be determined.No labeling or ifu inadequacies have been identified and review of complaint history revealed that occurrence rate does not exceed the control limits for this trend category.Therefore, no corrective or preventative action is required.

• Brand Name: COMMANDER 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: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 4954498
• MDR Text Key: 23232285
• Report Number: 2015691-2015-01906
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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