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

Model Number 9600LDS29A

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

Patient Problem Foreign Body Embolism (4439)

Event Date 09/26/2022

Event Type  Death  

Event Description

As reported by an edwards field clinical specialist, during a trans-subclavian tavr procedure, difficulties were encountered during the advancement of a 29mm sapien 3 valve and commander delivery system through the 16fr esheath.The devices were removed as a unit.A new valve, delivery system and sheath were prepared.Difficulties were encountered during valve alignment on the balloon, the valve was not properly mounted on the balloon.Due to the patient crashing and coding during the advancement of the valve, the valve was quickly deployed.Since the valve was not properly mounted, during deployment, the valve 'watermelon seeded' into the aorta.Unsuccessful attempts were made to move the valve to the correct position.Another sapien 3 valve was prepared, but not implanted due to the condition of the patient.The patient expired.

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.

Manufacturer Narrative

Corrected information: section h6.Additional information: section h10.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 3mensio was provided and revealed tortuosity and calcification present within the patient's subclavian artery and ascending aorta and the subclavian artery was undersized < 6.0mm.The device history review (dhr) review was performed and revealed no issues that would have contributed to the complaint events.A review of lot history did not reveal other complaints relating to the reported event.The commander delivery system ifu, device preparation training manual, device procedural training manual, and procedural manual supplemental for subclavian and axillary approach were reviewed for instructions and guidance.The procedural training manual provides guidance for 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 and 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.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.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.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.In addition, the procedural manual supplemental for subclavian and axillary approach provides guidance for patient screening via ct imaging.Ct screening should include left and right subclavian or axillary arteries, iv injection preferable from right side and left side access preferred due to: more favorable delivery angulation relative to aortic valve, extra length in arch for valve alignment and left internal carotid usually separate takeoff from arch.Right side access possible depending on tortuosity and right axillary has bigger dimensions, double angle and right carotid take off at the level of the subclavian artery.For each artery, evaluation should include specific measurements of the diameter - multiple locations, calcification - degree of location, tortuosity - degree and location, and depth of artery (axillary only for percutaneous access).Due to arm position during ct, may not be accurate.Reconfirm depth with ultrasound and confirm patency of carotid and vertebral artery.A 29mm thv size for minimum vessel diameter is > 6.0mm.Access characteristics that would preclude safe placement of sheath such as severe obstructive calcification, severe tortuosity or vessel diameters less than 5.5 and 6.0 mm.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 complaints for valve not aligned between markers and deployed and valve alignment difficulty or inability were unable to be confirmed as neither the complaint device nor applicable procedural imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr 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, 'deployed valve quickly after patients' pressure had dropped.Pusher was not pulled back balloon pushed valve up into ascending aorta' and 'the patient started to crash and code as we were advancing the second valve.' per 3mensio review, tortuosity and calcification, in addition to an undersized mld, were present within the patient's subclavian artery and ascending aorta.Obstructive calcification may have restricted the advancement of delivery system as the valve may have interacted with calcium nodes in the advancement pathway.Additionally, undersized vessels can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Tortuous anatomy can also present difficult bend angles for the devices to overcome.Per the fcs's response with regard to valve alignment difficulties that may have been experienced, it was 'hard to say as patient was crashing and i was not close enough to see.' while unable to confirm, it is possible that valve alignment difficulty was experienced during the procedure as the valve was reported not to have fully aligned prior to deployment.3mensio review revealed a tortuous anatomy and it was additionally reported, 'it was subclavian so not really a straight part in the ascending to align.' as such, it is possible that valve alignment was performed in a non-straight section of vasculature which can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and 'dive' into the flex tip.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of 'diving' (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.As reported, 'it started off where it was intended they watermelon seeded into the aorta because the balloon was not properly mounted.' per the case notes, 'the markers were not aligned when the 2nd valve was deployed.The patient was crashing and things were hurried'.Per training manual, 'before deployment, ensure that the valve is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker'.Failure to follow instructions can result in improper deployment.Due to the valve not properly aligned between valve alignment markers, the balloon may have inflated distally in the reported 'watermelon' shape and led to the movement into the aorta.In this case, available information suggests that procedural factors (incomplete valve alignment, misaligned valve on inflation balloon prior to deployment, valve alignment in non-straight section) and patient factors (tortuosity, calcification, vessel size) 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 product risk assessment no corrective or preventative action is required at this time.Review of edwards lifesciences risk management documentation as performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 corrective or preventative actions are required.

Manufacturer Narrative

During an administrative review it was noted that the field for the udi (d4) was omitted from the initial submitted mdr.The date of this report is 29-jun-2023.As such this mdr is being submitted as a corrected supplemental.

• 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: 15627284
• MDR Text Key: 301949737
• Report Number: 2015691-2022-08667
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240615(10)64398109
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 9600LDS29A
• Device Lot Number: 64398109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 06/29/2023
• Supplement Dates FDA Received: 12/06/2022; 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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): Death; Required Intervention
• Patient Sex: Male