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

Model Number 9600LDS29A

Device Problem Inflation Problem (1310)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

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.This is one of two manufacturer reports being submitted for this case.

Event Description

During a transfemoral valve in valve procedure, a 29mm sapien 3 valve was implanted in a failing non-edwards surgical aortic valve.Difficulties were encountered during the inflation of the sapien 3 valve.The distal end of the commander delivery system balloon inflated, but the proximal end of the balloon did not inflate.The initial valve landed too ventricular.A second sapien 3 valve was prepared and deployed in the initial sapien 3 valve where intended.No injury to the patient was reported.The patient was transferred to recovery in stable condition.Both valves remain implanted in the patient.

Event Description

During a mitral valve in valve procedure, a 29mm sapien 3 valve was implanted in a failing non-edwards surgical mitral valve.Difficulties were encountered during the inflation of the sapien 3 valve.The distal end of the commander delivery system balloon inflated, but the proximal end of the balloon did not inflate.The initial valve landed too ventricular.A second sapien 3 valve was prepared and deployed in the initial sapien 3 valve where intended.No injury to the patient was reported.The patient was transferred to recovery in stable condition.Both valves remain implanted in the patient.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021- 04246.

Manufacturer Narrative

The commander delivery system was returned to edwards for evaluation.The delivery system was fully inserted through loader assembly, the stylet was inserted and the system was locked at the default marker.No flex or fine adjust was used.The valve was not returned.No damage to inflation balloon was observed and 1ml of residual fluid was left in balloon.The balloon was unpleated and unfolded from use.Visual inspection revealed no abnormalities on the inflation balloon.Review of the provided 3mensio report revealed the patient's annulus with a previously implanted valve.During functional testing and dimensional analysis, the device was able to be inflated as designed.The fully inflated delivery system was held for 3 seconds and deflated in less than 20 seconds.Specifications were met.The instructions for use (ifu), device preparation manual, and procedural training manual were reviewed for instructions/guidance on device preparation/usage.Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.G.Kinked or stretched), or the expiration date has elapsed.Visually inspect all components for damage.Ensure the edwards commander delivery system is fully unflexed and the balloon catheter is fully advanced in the flex catheter.To prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Verify proximal balloon shoulder greater than 1 cm distal to the sheath marker.Unlock inflation device.Initiate rapid ventricular 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 controlled slow inflation.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon.Balloon should be fully deflated and un-flexed prior to retraction into sheath.Stop pacing and withdraw the balloon from the native valve in this case, the complaints were not confirmed based on the evaluation of the returned device.The investigation of the device revealed no indication that a manufacturing non-conformance contributed to the event.A review of the ifu and training manuals revealed no deficiencies.Per provided notes from site the root cause most likely the s3 secured itself on the pre-existing non-edwards valve and the commander delivery balloon slipped ventricular during inflation so that more of the distal part of the balloon was inflating before the proximal end of the balloon.As such it is possible the thv came into contact with the previously implanted valve, impeding the advancement of thv while the delivery system was advanced, causing the valve to move proximally on the delivery system.And during the inflation of the valve due to its position causing the inflation balloon to inflate distally first leading to the noted difficulties.Although a definite root cause was not able to be determined, the available information suggests that patient factors (previous valve), in addition to procedural factors (improperly aligned valve) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12197796
• MDR Text Key: 262510793
• Report Number: 2015691-2021-04244
• Device Sequence Number: 1
• Product Code: NPU
• 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,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR