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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Failure to Align (2522); Material Split, Cut or Torn (4008)

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

Event Date 11/16/2022

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.

Event Description

As reported by our edwards affiliate in canada, during a transcarotid tavr procedure, the esheath was inserted without issue.A 29mm sapien 3 valve and commander delivery system were then advanced through the sheath into the descending aorta.The valve alignment was performed in stages with the initial alignment done while the valve was in the sheath.The valve and delivery system were advanced past the end of the sheath and the valve alignment was completed in the straight section of the aorta.When the valve was in position for deployment and during inflation, blood was noted in the inflation device.The valve deployment was stopped.The valve and delivery system were pulled back into the sheath and removed without issue or injury to the patient.A new valve delivery system and sheath were prepared and successfully used.At the time of the report, the patient had been discharged to home in stable condition.The valve remains implanted in the patient.It was perceived that excessive tension build up during valve alignment may have contributed to the event.

Event Description

Additional information received.Pre-decontamination evaluation of the returned commander delivery system revealed the balloon was torn at the inflation balloon/crimp balloon (i/c) bond.

Manufacturer Narrative

Update to d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings and investigation conclusions) and h10 to reflect device evaluation.The 29mm commander delivery system was returned to edwards for evaluation.Visual inspection revealed that the crimp balloon was torn at the ic bond area.Functional testing found that the delivery system was able to be pulled toe full gross alignment with the balloon shaft to the warning marker, lock the device, and perform full fine adjust with no abnormalities.Dimensional testing of the double-wall thickness measurements of the crimp balloon was performed and the component was within specification.In addition, a video of the complaint device was provided and revealed that after removal from the patient, the delivery system leaked from the torn crimp balloon.A device history record (drh) review was completed and did not reveal any manufacturing non-conformances that would have contributed to the reported event.A lot history was completed and there was no other complaints related to this event.The commander delivery system ifu, device preparation manual, and procedural training manual were reviewed for instructions and guidance.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.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 and 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.Note that 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 include 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 balloon torn was confirmed based on evaluation of the returned device.However, the complaints for valve alignment difficulty was unable to be confirmed as the complaint was unable to be replicated with the devices returned and no applicable procedural imagery was provided for evaluation.No manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, lot history, 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.The complaint description states, 'the valve alignment was done in stages with initial alignment performed while valve was in the esheath.The delivery system with partially aligned valve advanced past the end of the esheath for the remaining alignment in the straight section of the aorta.No valve alignment steps were followed accurately.' as reported, valve alignment was partially performed inside the sheath.Performing valve alignment in the sheath may result in in high valve alignment forces, contributing the reported valve alignment difficulties.Furthermore, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.Likewise, the off-label use of the commander delivery system via the carotid artery may have also contributed to the reported event as the commander delivery system is not indicated for use in the transcarotid approach.Without the return of applicable imagery, a definitive root cause is unable to be determined.In this case, available information suggests that procedural factors (valve alignment performed in sheath, high alignment forces, off-label use) may have contributed to the reported 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: 15882728
• MDR Text Key: 306447947
• Report Number: 2015691-2022-09545
• 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,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9610TF29
• Device Lot Number: 64367875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0835-2019
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male