MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS26

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during deployment of a 26mm sapien 3 valve, the delivery balloon did not inflate to its full profile.With all the available volume in the inflation device introduced, the thv did not reach full deployment.Upon withdrawal of volume into the inflation device blood came back into the inflation device, indicating a balloon rupture.The delivery system was then removed and inspected.Upon visual inspection a small pinhole was observed in the shaft proximal to the main body of the balloon around the area of the triple marker.The thv remained implanted in the annulus but the decision was made to post dilate with a non-edwards bav with an inflation volume overfilled to 25.9mm.After two subsequent post dilatations, the valve was fully deployed and a very small mild paravalvular leak was noted.Per report, there was a slight kink noted in the pusher shaft after the commander system was positioned across the valve.The team felt as if the kink occurred during the introduction of the system through the esheath.It was discussed if the kink adversely affect the balloon shaft, leading to the balloon rupture.It was determined that no assumptions could be made as to the cause of the balloon burst.

Manufacturer Narrative

The delivery system was returned to edwards for evaluation.Visual examination revealed a pinhole on the crimp balloon approximately 4¿ from the distal nose tip, proximal to the triple marker band and a kink on flex shaft proximal to flex tip.No dimensional testing could be performed due to the condition of the returned device (mechanical damage / balloon leakage).Functional testing revealed that the device was unable to be de-aired, as a leak was observed at the location of the puncture.The complaint of balloon leakage was confirmed on the returned device; however, no manufacturing non-conformities were identified.A leak was observed on the crimp balloon during visual inspection and while attempting to de-air the device.It is unlikely that the delivery system left the manufacturing site with a pin hole on the balloon, as during manufacturing all devices undergoes multiple 100% inspections including leak testing.According to additional information obtained from the complaint site, ¿no tools were used to remove the cover.¿ these inspections make it unlikely that pre-existing damage on the balloon was present on the device before leaving the manufacturing facility.In this case, as reported a kink was observed on the flex shaft.There is no indication that this kink is related to the observed balloon leakage.No labeling or ifu inadequacies were been identified and review of complaint history did not reveal that occurrence rate exceeds the (b)(4) 2015 control limit for this trend category.Therefore, no corrective or preventative action is required.Method: actual device evaluated.Result: non functional defect.Known inherent risk of procedure.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 26MM
• 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: 5134614
• MDR Text Key: 27813233
• Report Number: 2015691-2015-02651
• 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
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/14/2015

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: 06/18/2017
• Device Model Number: 9600LDS26
• Device Lot Number: 60097006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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
• Patient Age: 89 YR