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

Model Number 9750CM26A

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

During a tavr procedure using a 26mm sapien 3 valve via transfemoral approach, the delivery system balloon ruptured at final deployment.The operator removed the delivery system back into 14fr esheath plus without any issues and then removed the delivery system.After removing the delivery system and esheath, the nose cone and part of the balloon stuck were stuck in the sheath.Angiographically nothing was left behind in the patient.No complications and the patient was stable post-procedure.

Manufacturer Narrative

The commander delivery system was returned to edwards for evaluation.Visual inspection revealed the following: delivery system distal tip and inflation balloon separated from the delivery system and stuck at the esheath, spring coil stretched out and adhesive present on the guidewire lumen.Functional testing was not performed as the complaint was confirmed through visual inspection.Dimensional testing was performed on the balloon single wall thickness along the edges of the burst location and all measurements were within specification.Post procedural imaging was provided and reviewed.The balloon burst radially at the proximal shoulder of the inflation balloon, nose tip and balloon material were not visible in the photo and the spring balloon was stretched.There was no lot number provided and a device history review nor a lot history was unable to be performed.The commander delivery system ifu, device preparation manual and device training manual were reviewed for instructions and guidance.The device training manual provides guidance on delivery system removal and balloon burst.Completely unflex the delivery system, ensure flex tip is still over the triple marker, ensure balloon lock is locked, ensure the balloon is completely deflated, pull the entire delivery system through the sheath, and maintain guidewire position in the aorta.Patient injury could occur if the delivery system is not completely unflexed prior to removal.If delivery system balloon bursts or leaks during deployment without thv embolization, do not use excessive force.Take care when crossing the thv, tracking back over the arch and removing the delivery system (through the tip of the sheath) and maintain guidewire position.If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following steps: attempt to visualize location of tear either in tee or via angio through the pigtail or catheter/delivery system, when removing, ensure the catheter/delivery system and wire are coaxial with the sheath tip.Watch under fluoro with every movement.Be patient and pull gently especially near tear and balloon shoulder transitions, if resistance is met near or at the sheath tip (force could result in additional tearing of the balloon material and the balloon material or tip coming off), if successful in pulling the entire balloon and delivery system tip into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position and do not attempt to pull the delivery system through the remaining length of the sheath.If unable to pull the entire balloon into the sheath, do not attempt to remove the exposed balloon through the entire peripheral vasculature, as there is risk of major complications.Conversion to surgery is recommended to remove the system and a surgeon should be in a position to be able to evaluate the situation.Based on a medical assessment of the size, tortuosity, and extent of calcification of the peripheral vessels, evaluate the risks and tradeoffs of carefully withdrawing the system into a more peripheral anatomy in order to allow a more localized surgical procedure.Consider use of an occlusion balloon to mitigate bleeding risks, especially if there is resistance encountered during withdrawal.If resistance is unacceptably high, convert to surgery rather than using excessive force to pull the sheath/delivery system to a different position.Ensure the valve is well opposed.If it is not, you must post dilate immediately with another balloon or delivery system and sheath.Take care when crossing the deployed valve to prevent potential embolization.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint for balloon burst, distal tip and balloon separated during use and difficulty or inability to withdraw system through sheath were confirmed by visual inspection of the returned device.However, no manufacturing non-conformance was identified during the evaluation.No visual abnormalities were observed on the returned sample.As reported, 'during a tavr procedure using a 26mm sapien 3 valve via transfemoral approach, the delivery system balloon ruptured at final deployment.' patient anatomy was not provided.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, potential calcified nodules and or over-inflation of the balloon can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In this case, procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.However, due to limited information a conclusive root cause was unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15905559
• MDR Text Key: 305885469
• Report Number: 2015691-2022-09617
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male