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

Model Number 9610TF26

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint device [commander delivery system, model 9610tf26 lot number 59976758 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 during a transfemoral tavr procedure, during the inflation of the delivery system only half of the contrast solution entered the balloon and the other part of the contrast solution ran out of the handle.Due to this, the balloon and valve didn`t expand completely.The physician decided to continue with rapid pacing and tried to inflate the system again with more contrast but the valve didn`t open completely due to the fact that most of the contrast leaked through the handle.The physician did a post dilatation with a 26mm balloon.The final result and position of the valve were good.The patient is doing well.

Manufacturer Narrative

The commander delivery system was returned to edwards for evaluation.Upon visual analysis, a small break in the balloon shaft proximal to the metal stop sleeve was observed.There were no other visual abnormalities noted.During functional analysis, leakage was observed from inside the handle.Dimensional inspection of the delivery system revealed no abnormalities, which would create dimensional interferences with the tailpiece, collet, and balloon shaft.During manufacturing, each commander delivery system is 100% inspected for mechanical damage (kinks, breaks) or missing/misplaced parts.The complaint for delivery system leakage was confirmed.The root cause of this failure was previously investigated as part of a capa.The primary root cause was determined to be the use of excessive force or bending during the valve alignment process.The following design/ procedural factors may contribute to the delivery system/balloon shaft being susceptible to this failure: ¿ balloon shaft component: bending of balloon shaft at the proximal stop sleeve can break the joint.Bending is considered plausible during clinical use.¿ clinical usage scenario: user inadvertently pulls the shaft past the yellow marker and bends the balloon shaft during gross valve alignment.Bending while the yellow marker is visible stresses the proximal bond.No manufacturing non-conformities were found in the returned sample.Available information suggests that procedural factors may have contributed to the event.Corrective actions are being addressed through a capa.

• 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: 5029116
• MDR Text Key: 24936091
• Report Number: 2015691-2015-02171
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2016
• Device Model Number: 9610TF26
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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