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

Model Number 9610TF29

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards brazilian affiliate, the patient underwent a double exchange procedure with a sapien 3 valve being implanted within a pre-existing surgical valve in the mitral position and an aortic exchange occurring at the same time.During deployment of the sapien 3 valve the delivery system balloon ruptured.As per medical opinion, the cause of the rupture was probably due to the ballooning the frame of the transcatheter aortic heart valve.

Manufacturer Narrative

Added h.6 type of investigation and investigation findings.Corrected h.6 type of investigations.The device was not returned for evaluation.A dhr review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to burst balloon.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The ifu, device preparation manual, and device training manual were reviewed.During thv deployment, check to ensure the thv is exactly between the valve alignment markers, the flex tip is on the triple marker, and the balloon lock is locked.Perform deployment by unlocking the inflation device, initiating rapid pacing ensuring 1:1 capture, sbp <= 50 mmhg, and pulse pressure <10 mmhg, confirm placement of center marker within optimal initial center marker zone.Begin initial deployment with a slow controlled inflation.Fully inflate and hold for 3 seconds to ensure complete deployment and completely deflate the balloon.Stop pacing and withdraw the balloon from the native valve.Ensure full inflation of balloon during deployment and stability of the delivery system.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.Do not exceed 20 seconds for inflation and deflation of the delivery system.Always maintain control of the plunger of inflation device when releasing it.If balloon bursts, do not use excessive force.Take care when removing the balloon through the tip of the sheath.Maintain guidewire position.If re-dilation is needed, use a new balloon.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.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.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.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 a product non-conformance could not be confirmed and no ifu/training manual deficiency was identified, escalation to a pra is not required.Since no edwards defect could be confirmed, no corrective/preventative actions are required.The balloon burst was unable to be confirmed as neither the device nor applicable imagery was returned for the evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.Additionally, a review of the lot history, dhr and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, 'at the time of mitral valve implantation, balloon ruptured.As per medical opinion, cause of the rupture probably was due to the balloon touched the stem of the aortic sapien'.No additional information or imagery was provided.Procedural factors such as interference with an existing bioprosthetic may have contributed to the reported event.However, due to no device return or relevant procedural imagery provided, a definite root cause was unable to be determined.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12492780
• MDR Text Key: 272518603
• Report Number: 2015691-2021-05250
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)220804(10)63409186
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: 9610TF29
• Device Lot Number: 63409186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1