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

Model Number 9750CM26A

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a tf tavr case, during inflation the physician stopped at partial inflation due to proximal movement of valve on balloon, this created a partial inflation of the valve.The case was converted to surgical avr to ensure a predictable outcome due to challenging anatomy.The tavr devices were removed during the savr.

Event Description

Per additional information received, after the valve movement during deployment the valve and delivery system were pulled out of the annulus to the descending aorta.The right common femoral artery was accessed.The team tried to advance a wire through the unexpanded portion of the valve to deliver a separate independent balloon for re-expansion in the descending aorta.Unfortunately, this was unachievable, as the valve was significantly cramped in the current position.The team then tried to run a wire across the valve through the right radial artery, but was again unsuccessful.It was at this point that the case was converted to surgical aortic valve replacement.They grabbed the valve with kelly clamps, removed it, then withdrew the delivery system and sheath.

Manufacturer Narrative

Corrected information in b.5 and b.7 based on new information received.Added h.6 device code.Investigation is ongoing.

Manufacturer Narrative

The device was not returned for evaluation.A device history review (dhr) 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 valve movement or withdrawal difficulty.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The ifu, device preparation manual, and procedural manual were reviewed.During valve alignment, unlock, pull the balloon catheter straight back at the y-=connector until part of the warning marker is visible and lock.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock.Check delivery system before valve alignment.If kinked, do not use.Maintain guidewire position in the left ventricle during valve alignment.Manage guidewire position.Guidewire can move proximally during valve alignment.The warning marker indicates the balloon catheter is approaching a hard stop.Do not pull past the warning marker.Slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap.Fine adjustment indicator shows how much fine adjustment is left.If additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.A gap between the thv and distal valve alignment marker may result in difficulty crossing.An overlap cannot be reversed and may prevent proper thv deployment.Fine adjustment wheel functions only when the balloon is locked.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.Compression may be observed in the distal portion of the flex catheter during valve alignment.Diving may be observed between the thv and the flex catheter tip during valve alignment.To correct, move to a different straight section of the aorta (for diving only).If using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible.If using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.Thv moves in only one direction relative to the balloon.If valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.Pull back flex catheter so it is off the balloon during deployment.Unlock the balloon lock.Slowly move back flex catheter (handle) while maintaining position of balloon catheter.Position flex tip in the middle of the triple marker.Lock the balloon lock.Placing flex tip on the middle of the triple marker will enable fine adjustment in either direction during thv positioning.Positioning flex tip on the triple marker prior to thv deployment will help maintain stability while ensuring unobstructed inflation during deployment.Partially unflexing may help when pulling back the flex catheter.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 no product non-conformance was confirmed, a product risk assessment (pra) is not required.However, a pra was previously initiated to investigate and document the valve movement on balloon issue and its associated risks.The risks outlined in the pra remain the same; the pra documents the potential for procedural delay from thv movement on working length, which did occur during this event.No pra re-escalation is required at this time.A corrective action preventative action (capa) was initiated to document the investigation and drive corrective/preventive actions as appropriate.The investigation revealed that high tension can lead to valve movement in the proximal direction when the flex catheter is retracted prior to deployment.The valve movement on the balloon and withdrawal difficulty were unable to be confirmed as neither device nor applicable imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to be perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.A product risk assessment (pra) was previously initiated to investigate and document the valve movement on balloon issue and its associated risks for the commander delivery system.In the pra, build-up tension within the delivery system during the procedure (e.G., via valve alignment in a non-straight section, torquing of the system, patient tortuosity, etc) was identified as a possible cause of valve movement on balloon.Per the description, ''during inflation the physician stopped at partial inflation due to proximal movement of valve on balloon, this created a partial inflation of the valve.'' as suggested by the pra, if the patient's anatomy exhibits some degree of tortuosity, this can potentially create high tension on the delivery system when performing valve alignment.In this case the provided patient medical records reported the patient has a complex anatomy with tortuosity.It is likely that the proximal valve movement during deployment of the thv was a result of the high tension relieved off the system, causing the valve to be mispositioned prior to its deployment.If the valve is deployed in this configuration, it can lead to asymmetrical valve expansion during deployment as reported.As such, available information suggests that patient factors (tortuous) likely contributed to the event.However, due to lack of device or imagery, a definitive root cause is unable to be determined.

• 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: 13563959
• MDR Text Key: 288826326
• Report Number: 2015691-2022-04059
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)231013(10)64039261
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: 9750CM26A
• Device Lot Number: 64039261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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 Sex: Male