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

Model Number 9600LDS29A

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards field clinical specialist, during deployment of a 29mm sapien 3 valve in the aortic position via transfemoral approach, the 29mm commander delivery system balloon burst.The valve was fully deployed.There were no other issues and no injuries.The device was discarded.

Manufacturer Narrative

The device was not returned therefore a device evaluation could not be performed.Patient imagery was provided for review and presence of calcification on annulus and calcified leaflets were observed.A device history review dhr was unable to be performed due to unavailable device work order information.A lot history review was unable to be performed due to unavailable device work order information.Due to the work order information was not provided the effective revisions at the time of complaint occurrence were referenced.The inspections and tests described below are representative of the processes that the delivery system would have undergone during manufacturing.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 following instructions were reviewed instruction for use ifu for commander delivery system with sapien 3, device preparation manual, and procedural training manual.Balloon burst 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.Maintain guidewire position.Check for pv leaks under echo.If post dilation needed use a new delivery system and sheath.Take care when crossing the deployed valve to prevent potential embolization.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.Do not force 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.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.As the reported event was unable to be confirmed, a complaint history review is not required.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.Since no manufacturing non conformances or ifu training manual deficiencies were identified no escalation to a product risk assessment pra was required.Since no edwards defects were identified no corrective preventative actions capa are required.The reported event was unable to be confirmed.As the complaint device was not returned engineering was unable to perform any visual functional or dimensional analysis.Therefore no manufacturing nonconformances were able to be identified.Additionally as work order information was not provided reviews of the dhr and lot history were not able to be performed.However a review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu training materials revealed no deficiencies.As reported in this complaint during deployment of a 29mm sapien 3 valve in the aortic position via transfemoral approach the 29mm commander delivery system balloon burst.The valve was fully deployed.Additionally patient imagery showed presence of calcification on the annulus leaflets.It is possible that calcification present in the landing zone could have weakened the balloon material contributing the burst.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Additionally, the note on salesforce attachment states that excessive volume was used to inflate the balloon plus 2cc.Excessive fluid used for inflation can also negatively impact the balloon by subjecting it higher pressure levels than the rated burst pressure of the balloon.As such, available information suggests that patient factors calcification and procedural factors over inflation likely contributed to the complaint event.

• 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
• MDR Report Key: 11386811
• MDR Text Key: 242728404
• Report Number: 2015691-2021-01550
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1