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

Device Problems Bent (1059); Fluid/Blood Leak (1250); Inflation Problem (1310); Kinked (1339); Loose or Intermittent Connection (1371); Retraction Problem (1536)

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint device [commander delivery system, model 9610tf26 and lot# 60067166 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 has 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

As reported, 26mm sapien 3 case by tf approach.The valve was crimped on the v2.1 commander as normal.Advancing the valve through the e-sheath was without problems.The valve alignment work perfect.Then advancing through the aorta, crossing the aortic arch and positioning of the valve in the native annulus.Then it was not possible to re-tract the pusher before valve deployment.They pulled with a lot of force and while trying to retract the pusher, the balloon shaft got bent and kinked.After all the maneuvers to retract the pusher, the doctor felt that the valve alignment wheel was kind of loose and also it seemed the valve moved out of its optimal position on the balloon.Therefore it was decided the retrieve the delivery system and valve to the descending aorta and deploy the valve there.When attempting to inflate the balloon, the contrast liquid leaked out of the handle and the valve could not be inflated.In order not to injure the patient, it was decided to remove the sheath and delivery system with valve via a surgical cut down.This was done well and new devices were prepared.Then the implantation was completed successfully.The doctor said that he believes that due to the extreme force they used with bending of the balloon shaft in order retract the pusher, they must have damaged the balloon shaft inside the handle.

Manufacturer Narrative

During the visual inspection of the returned delivery system a break was observed between metal stop sleeve and balloon shaft at proximal bond.The metal braid was observed to be intact.No other visual abnormalities were observed.The delivery system was dimensionally measured for any components that could possibly interact during the valve alignment function.All measured component dimensions are within specification except for the balloon shaft od proximal to stop sleeve, which was undersized.This is due to the additional tensile load placed on the balloon shaft by the physician stretching the shaft while trying to retract the flex shaft.During manufacturing, the delivery system undergoes 100% inspection for the following: mechanical damage (e.G.Kinks, breaks), collet engagement (verifying locking functionality) and shaft clearance, and fine adjust function.The reported balloon shaft resistance with flex shaft was confirmed but no manufacturing non-conformances were identified.During functional testing, resistance was felt while placing the delivery system from valve alignment position to the default position.According to the cer, ¿it was not possible to re-tract the pusher before valve deployment.They pulled with a lot of force while trying to retract the pusher.¿ while a definitive root cause was unable to be determined, available information supports that procedural factors may have contributed to the reported balloon shaft resistance with flex shaft.The reported delivery system leakage was confirmed.During functional testing, the device could not be de-aired.In addition, a break in the balloon shaft was observed at the proximal end of the stop sleeve.According to the cer, ¿the doctor said that he believes that due to the extreme force they used with bending of the balloon shaft in order retract the pusher, they must have damaged the balloon shaft inside the handle.¿ based on available information, it is supported that procedural factors contributed to the leakage.The root cause of this type of failure was investigated as part of a capa.The primary root cause for this type of failure (balloon shaft fracture) was determined to be the use of excessive force or bending during the valve alignment process.Balloon shaft fracture (as seen in this returned compliant device) results in a gross leak in the delivery system and potentially the inability to finalize valve alignment.

• 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: 4926605
• MDR Text Key: 24311734
• Report Number: 2015691-2015-01776
• 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
• Remedial Action: Other
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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