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

Model Number 9600LDS29A

Device Problems Inflation Problem (1310); Kinked (1339); Difficult to Remove (1528); Material Separation (1562); Use of Device Problem (1670)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the territory manager, during a complex pulmonic case on a patient with congenital and anatomical issues, the commander delivery system had to travel through a great deal of tortuosity to reach the patient's valve.Due to the twists and some kinks made to the delivery system during the tracking phase, there was difficulty experienced inflating and deflating the balloon.The delivery system was pulled into the sheath however, the partially inflated balloon resulted in a great deal of resistance in the sheath and the nose cone and balloon of the delivery system came off while pulling the delivery system out of the esheath.The heart team was prepared for this and made sure the removal was controlled and that everything was captured within the sheath and successfully removed from the body.A valve in valve procedure was performed, placing a second 29mm sapien 3 valve within the first, under-inflated valve.The end result was satisfactory and the patient is doing great.The delivery system was discarded.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences.A photograph from the procedure site was provided.The distal tip was separated from the delivery system at the crimp balloon and guidewire lumen, just proximal to the valve crimping marker.Additionally, fluoroscopic imagery was provided and the delivery system was observed to be bent during the procedure.The first valve appeared to be under-deployed.The second valve was observed being implanted within the first valve.A dhr review was unable to be performed because the work order information was not provided.A review of the complaint history revealed that the occurrence rate did not exceed the october 2017 control limit for the trend category of ¿inflation, deflation difficulty¿.No ifu/training deficiencies were identified.The instructions and inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the complaint event.Since the delivery system was not provided and the imagery/photograph provided insufficient evidence for the following complaint events, the complaints for ¿delivery system ¿ inflation difficulty-partial or slow,¿ ¿delivery system ¿ kinked, bent,¿ and ¿delivery system ¿ deflation difficulty-partial or slow¿ were unable to be confirmed.Based on the provided photograph, the complaints for ¿delivery system ¿ withdrawal difficulty-through sheath¿ and ¿distal tip, nose tip ¿ separated¿ were confirmed.Due to the unavailability of the relevant device, engineering was unable to perform any visual, functional or dimensional analysis.As a result, a manufacturing non-conformance was unable to be determined.A review of manufacturing mitigation supports that the delivery system has proper inspections in place to detect issues related to the reported based on the complaint history review, there is no evidence to support a manufacturing non-conformance contributed to the complaint.It was noted in the event description that there was ¿a great deal of tortuosity¿ and ¿twists and some kinks¿ were in the delivery system.Patient factors such as tortuosity can create a difficult path for the delivery system causing it to kink or bend.Furthermore, it was noted that during navigation the flex tip, or pusher, was pulled back during navigation through the tortuous vessel.The flex tip serves as support for the balloon catheter, guidewire lumen, and valve during tracking.With the flex tip pulled back prior to tracking, the lack of support on the balloon catheter and guidewire lumen could have resulted in either component kinking.Per the ifu and training materials, the flex tip should be pulled back after tracking to the native annulus.Failure to follow the recommended ifu and training materials may have resulted in a kink or bend in the device.As a result of the delivery system twists, kinks, bends and vessel tortuosity, inflation and deflation issues could have occurred.A twist or kink in the delivery system would have reduced the inner diameter of the balloon catheter restricting the flow of the saline solution to the balloon from the inflation device and vice versa.Based on the information provided, ¿the partially inflated balloon resulted in a great deal of resistance in the sheath and the nose cone and balloon of the delivery system came off while pulling the delivery system out of the esheath.¿ procedural factors such as residual fluid in the balloon as a result of the deflation difficulty could have contributed to the withdrawal difficulty.If the balloon is not fully deflated and residual fluid remains in the balloon during retrieval of the delivery system through the sheath, the balloon od may be too large to withdraw through the sheath tip.Furthermore, access vessel tortuosity can increase the likelihood of withdrawal difficulty as tortuosity can cause non-coaxial retrieval of the balloon catheter through the sheath.It was noted, that the access vessel had ¿a great deal of tortuosity.¿ additionally, the angle of withdrawal could have contributed to the withdrawal difficulty as this may also have caused a non-coaxial retrieval of the balloon catheter.Withdrawal difficulty, possibly due to tortuosity or residual fluid in the balloon, may have contributed to the distal tip separation.In addition, a kink as described above could have been at the location of the break.Manipulation of the device leading to a kink or bend in the guidewire lumen and crimp balloon material could have reduced the integrity of the materials resulting in a separation during the increased withdrawal forces.Available information suggests that patient and/or procedural may have contributed to the complaint event.However, a definite root cause is unable to be determined.Since no manufacturing non-conformance or ifu/training deficiencies were identified, no corrective or preventative actions are required.Additionally, no product non-conformance was identified and the occurrence rates did not exceed the complaint control limits for october 2017, a product risk assessment (pra) is not required.

• Brand Name: EDWARDS 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: 7031511
• MDR Text Key: 92874327
• Report Number: 2015691-2017-03831
• 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: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR