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

Model Number 9610TF29

Device Problems Failure to Align (2522); Malposition of Device (2616)

Patient Problems Foreign Body Embolism (4439); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  Injury  

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.

Event Description

As reported by our edwards affiliate in france, a 29mm sapien 3 valve was deployed in the aortic position via the transfemoral approach.Prior to deployment, it was noted that the valve was slightly at a different level from the balloon.Despite this, the decision was made to deploy the valve.Following inflation, the valve 'slid' into the left ventricle.A second sapien 3 valve was going to be prepared; however, the decision was made to convert the procedure to open surgery.The initial sapien 3 valve was explanted, and a surgical valve was implanted.At the time of the report, the patient was in stable condition and doing well.

Manufacturer Narrative

Update to h6 (component code, impact code, clinical code, device code [correction], type of investigation, investigation findings and investigation conclusions) and h10 to reflect engineering evaluation.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record (drh) review was completed and did not reveal any manufacturing non-conformances that would have contributed to the reported event.The commander delivery system with s3 ifu, device preparation manual, and procedural training manual were reviewed for guidance and instructions.The procedural training manual provides guidance on 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 and check delivery system before valve alignment.If kinked, do not use.Maintain guidewire position in the left ventricle during valve alignment and slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, and the 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 lock is locked and 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.Additional consideration includes: compression may be observed in the distal portion of the flex catheter during valve alignment, and 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 and 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.No ifu or training deficiencies were identified.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.The complaint for valve alignment difficulty or inability was unable to be confirmed as neither the complaint device nor applicable imagery were not returned for evaluation.Due to 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 device history record and lot history 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, 'difficulties were felt during valve alignment and the valve alignment was performed in a non-straight section of the aorta' and 'before the deployment, the valve was slightly at a different level from the balloon.Despite this, it was decided to deploy and implant the valve.The valve expanded asymmetrically and after the inflation, the valve felt into the left ventricle.' per provided medical opinion, 'bad pacing' and 'not exactly centered' valve alignment caused the thv to slide into the ventricle.As there was no reported difficulty during device preparation (during loading the thv into loader where the balloon shaft is pulled to default position and the balloon lock is engaged), it is likely that the failure mode was not present on the device out-of-box.Per training manual, valve alignment is supposed to be performed in a straight section of the anatomy, otherwise, there may be difficulties performing this step with may lead to delivery system damage and inability to inflate the balloon properly.In this case, available information suggests that procedural factors (performing valve alignment in a non-straight section of the anatomy, loss of pacing capture) may have contributed to the complaint event.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action, nor pra is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY
• 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: 15992584
• MDR Text Key: 305583618
• Report Number: 2015691-2022-10051
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 9610TF29
• Device Lot Number: 64415054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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