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

Model Number 9600LDS23J

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), during the preparation of the transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 valve, there was valve movement on balloon.The valve was pulled back to the distal aortic arch and implanted there.The second valve was prepared and implanted.Final angiography confirmed no vascular damage, and the procedure was completed with no injury to the patient.

Manufacturer Narrative

The following report fields have been updated due to additional information received: g3, h6.The edwards commander delivery system was not returned for evaluation.A review of the device history record (dhr) 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 the complaint codes.As no device was returned, and no imagery was returned.There is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The instructions for use (ifu)/labeling training were reviewed for the commander delivery system, device preparation, and procedural training manuals.Per the warnings/precautions: visually inspect all components for damage.Ensure the delivery system is fully unflexed and the valve alignment wheel is adjacent to the handle.To prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Ensure there is no residual fluid left in the balloon to avoid potential difficulty with valve alignment during the procedure.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.No ifu/training deficiencies were identified.The complaint for "navigate and position catheter to target location - thv moves on balloon working length during positioning" was unable to be confirmed.There was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.A product risk assessment (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 off working length, which did occur during this event.Therefore, no pra re-escalation is required at this time.The investigation revealed that high tension can lead to valve movement in the proximal direction when the flex catheter is retracted prior to deployment.Global refresher training was provided, emphasizing steps to reduce tension in the system that can lead to valve movement.Since no edwards defects were identified, no corrective/preventative actions are required.The pra captures the prior investigation of this failure mode where high tension conditions can potentially result in proximal valve movement during flex tip retraction.Tension in the system may be induced by patient and procedural factors such as tortuosity and performing valve alignment in a non-straight section.Per the event description, the patient had a tortuous anatomy.It is possible valve alignment was performed in a non-straight section of the aorta, which can cause the thv to unseat from the flex tip (non-coaxial placement of valve in relation to the flex tip) during alignment and "dive" into the lumen of the flex tip.If the thv is unseated during alignment, it can result in additional valve alignment forces.It is likely that the tension was built during valve alignment and was released during flex tip retraction causing the valve to be mispositioned between the markers prior to deployment.Per the training manual, "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." the complaint for "navigate and position catheter to target location - thv moves on balloon working length during positioning" was 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.However, no manufacturing non-conformances were identified during evaluation.Available information suggests patient factors (tortuosity) and procedural factors (device built up tension) contributed to the reported event.A pra was previously initiated to investigate and document the valve movement on balloon issue and its associated risks and corrective and preventative action was previously initiated to document the investigation and drive corrective/preventive actions as appropriate.No additional escalation is required at this time.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.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.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.In this case, patient factors (tortuosity) and/or procedural factors (built up tension) may have contributed to the valve being implanted in a non-target location, the distal aortic arch.Valve deployment in unintended location is listed in the instructions for use (ifu) as a potential risk associated with the tavr procedure, the bioprosthesis, and the use of its associated devices and accessories.There may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a non-target location, typically in the descending aorta.

• 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
• 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: 13072436
• MDR Text Key: 282712338
• Report Number: 2015691-2021-07010
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: 9600LDS23J
• Device Lot Number: 63742484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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 Age: 83 YR
• Patient Sex: Female