As reported by a field clinical specialist, an inpatient with an aortic balloon pump had aortic stenosis and it was decided to perform a tavr procedure with a 26 mm sapien 3 valve in the native aortic valve via transfemoral approach. during the valve alignment portion of the procedure, the commander delivery system balloon would not come all the way inside the valve.The alignment was done partially on the aortic arch to avoid the aortic balloon pump.When the delivery system balloon was pulled back into the crimped valve, there was tension noticed on the system and the balloon only came half-way inside the valve.When the fine adjust was used, the balloon would not come all the way in the valve. it was decided to remove the devices.An attempt to pull the entire delivery system (with the balloon partially in the valve) into the 14 fr esheath was not successful.The crimped valve got stuck in the left common iliac.They were able to get the valve to go back up the aorta and deployed it in the descending thoracic aorta.The delivery system and esheath were removed.The balloon pump was removed and a second sheath, delivery and valve were introduced and successfully deployed.After deployment, it was noticed that there was a major tear in the left common iliac (the team believes from the crimped valve that was stuck there before).This injury was treated with covered stents.The patient had to receive 4 units of blood and is recovering from the procedure.Per medical opinion, as valve alignment was not done in a straight segment of vessel, the tip of the delivery system balloon was over the arch and above the balloon pump, which likely contributed to the event.The patient is in stable condition.
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The product was not returned for evaluation.Procedural imagery provided by the site showed the crimped valve profile was larger than the flex tip due to the valve being partially over the inflation balloon.The valve was deployed unevenly in the thoracic aorta.It was potentially caused by the valve being partially over the inflation site as the inflow side of the valve was larger than the outflow side of the valve.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.As the complaint was unable to be confirmed and the control limits for the applicable trend category were not exceeded for the monthly review a complaint history review was not required.The instructions for use (ifu), device preparation and the training manual were reviewed and no deficiencies were identified.It is to be noted 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, per the ifu do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.During the manufacturing process, the device was visually inspected and tested several times.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that it is unlikely that a non-conformance contributed to the reported complaint.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 delivery system withdrawal difficulty from valve, vasculature and handle fine adjustment difficulty were unable to be confirmed as the complaint device was returned.No manufacturing non-conformance could be determined without device 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 event.Additionally, a review of the ifu and training manual revealed no deficiencies.As reported, ¿the balloon alignment was done partially on the aortic arch to avoid the aortic balloon pump.When the balloon catheter in the delivery system was pulled there was tension noticed on the system, and the balloon only came halfway inside the valve.When the fine adjust was used, the balloon wouldn¿t come all the way in the valve.¿ in this case, the valve/balloon alignment was performed at the non-straight section (aortic arch), which could create a challenging pathway for the valve alignment.And it was resulting in fine adjust difficulty due to the either compression at the distal portion of the flex catheter or diving between the valve and the flex catheter tip since tension was noticed when pull balloon catheter straight back to warning marker per reported.Under the compression or diving condition, the fine adjustment wheel function would be potentially restricted.Per ifu/training manual, ¿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.¿ as such, available information suggests procedural factors (valve alignment at non-straight section) may have contributed to the fine adjust difficulty.However, a definitive root cause was unable to be determined at this time.As reported, ¿when the balloon catheter in the delivery system was pulled there was tension noticed on the system, and the balloon only came halfway inside the valve¿.Per the imagery review, the crimped valve had larger profile compare to the flex tip, which was indicating that the crimped valve had partially expanded during the valve alignment.Furthermore, excessive force applied to pull balloon catheter, which could lead to valve partial expanded, and enlarge the valve profile at outflow.If the common iliac had smaller mld (minimum luminal diameter), the larger valve profile could potential stuck at the common iliac.However, a definitive root cause was unable to be determined.As such, available information suggests that procedural factors (excessive manipulation during the valve alignment) may have contributed to the withdrawal difficulty of the valve through the patient¿s vasculature.Due to the unavailability of the device it cannot be determined if a manufacturing non-conformance contributed to the reported events.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursion above the control limits are assessed and documented as part of this monthly review.Since no product non-conformances or ifu/training deficiencies were identified during the evaluation, no product risk assessment, corrective or preventative actions are required.
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