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During implant of a 26 mm sapien 3 valve in the aortic position using subclavian approach, there was difficulty during valve alignment.Four attempts were made to align the commander delivery system balloon on the valve.The valve was misaligned approximately 5mm proximal.Upon initial valve deployment, the balloon slipped ventricular.The valve was able to be repositioned in the annulus, however, the balloon could not be aligned on the valve.When the atrion was pulled negative, blood back filled into the atrion.The balloon had ruptured.Several attempts and manipulations were made with the commander delivery system and the balloon to try to get it free.However, the balloon material was caught in the valve struts and would not come out.The operator performed a cut-down in order to remove the delivery catheter and valve.Once the subclavian vein was exposed, damage and bleeding of the subclavian vein was observed.A vascular surgeon came in to repair the vein and fully expose the subclavian artery.The 14fe esheath and commander delivery system and valve were in the subclavian artery.The tip of the catheter and valve were in the ascending aorta.The patient became unstable and echo showed severe aortic insufficiency.New devices were prepared and a 26mm sapien 3 valve was successfully deployed using transfemoral approach, even though this approach was deemed unfavorable due to the patient¿s abdominal aneurysm.After approximately 10 minutes of chest compressions the patient stabilized.After the patient stabilized, several more attempts were made to remove the commander, but all were unsuccessful.The operator attempted to pull the delivery system and valve into the esheath, but was unsuccessful.Then the commander delivery system was pulled as hard as possible and it broke free.However, the commander balloon wire port was still attached with about 80 cm of the shaft outside the body.The commander was removed, but the valve with the balloon were lodged in the innominate artery.The.035 wire sticking out of the nose cone was able to be snared, but the valve and balloon would not move.A digitally subtracted angiogram showed both carotids and the innominate artery filled, and there was a faint filling of the subclavian artery.Due to the prolonged period of time that the patient had been under anesthesia, the case was aborted.The.035 wire was removed, and then the wire shaft of the commander balloon catheter was cut just at the entry of the arteriotomy.The patient¿s incision was closed.The patient received 3 units of blood during the case.The patient was transferred to icu on a ventilator in stable condition.It was planned to surgically remove the valve and remaining part of the balloon catheter at a later date.However, the patient expired the following day.Upon withdrawal of the esheath a small, minor tear at the tip was observed.A tortuous right subclavian anatomy was thought to have contributed to stored tension in the commander device which lead to the valve alignment difficulty.It was considered to be possible that the balloon ruptured during valve alignment due to the stored tension in the delivery system.The system was able to move into valve alignment position during device prep.Valve alignment was attempted in a straight section of the aorta.There was difficulty during fine and gross alignment.One fairly firm push was given while crossing the valve.There was coaxial alignment of the delivery system upon reentry into the distal end of the sheath, but the balloon was separated off the outer blue shaft and the copper filling lumen of the balloon and the balloon material were stuck in the undeployed valve.
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The devices were not returned to edwards lifesciences for evaluation.Therefore visual, functional, and dimensional analysis could not be performed.The site provided imagery.3mensio of the access vasculature was provided showing the right subclavian access was tortuous.An image showed the thv was asymmetrically deployed and the flex tip flush against the thv.Digital subtraction angiography showed the distal balloon assembly separated in the subclavian anatomy.A second valve was able to be successfully deployed through femoral access while the initial set of devices (asymmetrically deployed thv) remains in the subclavian.A photo showed the commander delivery system balloon separated at the crimp balloon area.The distal balloon assembly and guidewire lumen were missing from the device.Review of lot history revealed no other similar complaints.Dhr review did not reveal any manufacturing non-conformance that would have contributed to this complaint event.A review of the complaint history from july 2019 to june 2020 revealed other similar returned complaints, but no manufacturing non-conformances that would have contributed to the complaints were identified.The control limits for the respective complaint trend category was not exceeded in the complaint.The ifu, device preparation training manual, procedural training manual, and procedural manual were reviewed for instructions/guidance for preparation and use of the devices.Per the procedural training manual, 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.Check delivery system before valve alignment.If kinked, do not use.Note: manage guidewire position.Guidewire can move proximally during valve alignment.Note: the warning marker indicates the balloon catheter is approaching a hard stop.Do not pull past the warning marker.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.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: 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.Note: do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Warning: do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.Additional considerations: compression may be observed in the distal portion of the flex catheter during valve alignment.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.If using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.Warning: 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.The procedural training manual provides guidance on thv retrieval through sheath: thv can be retrieved through sheath only before thv deployment (still crimped), ensure the thv is centered on the flex tip, ensure delivery system is locked, verify the flex catheter is completely unflexed, retract the thv and delivery system into the sheath and just past the sheath tip, ensure the edwards logo on the sheath handle is facing upward and withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not re-use the sheath, thv or delivery system once thv is retrieved.Note that the crimped thv aligned on the balloon is larger than the crimped thv off balloon, take care if deciding to retrieve.In addition, do not force the thv into the sheath, if resistance is felt, the thv may be caught on the sheath, stop, advance thv past the sheath tip and ensure thv is centered on the flex tip, and rotate the delivery system before trying again.Retrievability is based on preclinical testing.No ifu/training deficiencies were identified.During manufacturing of the delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformances contributed to the reported events.The complaints were all confirmed through review of provided imagery.A review of provided imagery revealed no manufacturing nonconformance.A review of the dhr, lot history, complaint history, and manufacturing mitigations revealed no indication that a manufacturing nonconformance contributed to the complaint.Additionally, a review of ifu and training materials revealed no deficiencies.A review of similar complaints suggests that tortuosity can contribute to the events reported in this complaint.Tortuosity was present in the chosen right subclavian access.Tortuosity may result in increased valve alignment forces.Additionally, if the user performed valve alignment in at a bend or angle the thv may unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during alignment and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the thv is unseated during alignment, it can result in even higher than usual valve alignment forces and can create tension in the system to achieve final alignment position.Per the report, tortuous right subclavian anatomy was thought to have contributed to stored tension in the commander device which lead to the valve alignment difficulty.It was considered to be possible that the balloon ruptured during valve alignment due to the stored tension in the delivery system.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a risk assessment.If high tension is present in the system during alignment (e.G.From performing valve alignment in tortuous vasculature or at an angle), it may have resulted in increased forces being applied to the bond area, resulting in the reported balloon damage.As described in the training manual states ¿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¿.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (valve alignment in non-straight section of anatomy) may have contributed to the reported event.Due to the inability to fully align the valve and damage to the balloon reported during inflation, the valve was partially deployed.As described in the training manual, the thv can only be retrieved through the sheath prior to deployment.A partially deployed valve would likely have a larger diameter, contributing to the reported withdrawal difficulty.Additionally, it is possible that subclavian access tortuosity may have resulted in non-coaxial withdrawal of the delivery system into the sheath, further contributing to the reported difficulty.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (withdrawal of a partially deployed valve) may have contributed to the reported delivery system ¿ withdrawal difficulty ¿ valve, through sheath event.As described above, there was difficulty withdrawing the undeployed valve into the sheath.It is possible excessive manipulation was used to attempt to overcome the reported resistance, causing the distal end of the delivery system to separate.Per the report, the commander delivery system was pulled as hard as possible and it broke free.While a definitive root cause is unable to be determined, available information suggests that procedural factors (excessive manipulation to overcome withdrawal difficulties) may have contributed to the reported distal tip, nose tip ¿ separated event.According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.In this case, the cause for the injury to the subclavian artery was likely due to patient and procedural factors.The complaint for ¿balloon ¿ torn¿ was confirmed.No manufacturing non-conformances were identified during the evaluation.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (valve alignment in non-straight section of anatomy may have contributed to the reported event.No labeling or ifu inadequacies have been identified and review of the complaint history revealed that the occurrence rates do not exceed the trigger for additional review.Per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a risk assessment.The complaint for ¿distal tip, nose tip ¿ separated¿ was confirmed.No manufacturing non-conformances were identified during the evaluation.While a definitive root cause is unable to be determined, available information suggests that procedural factors (excessive manipulation to overcome withdrawal difficulties) may have contributed to the reported event.No labeling or ifu inadequacies have been identified and review of the complaint history revealed that the occurrence rates do not exceed the trigger for additional review.Therefore, neither a risk assessment nor corrective/preventative action was required.The complaint for ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿ was confirmed.No manufacturing non-conformances were identified during the evaluation.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (valve alignment in non-straight section of anatomy may have contributed to the reported event.No labeling or ifu inadequacies have been identified and review of the complaint history revealed that the occurrence rates do not exceed the trigger for additional review.Therefore, neither a risk assessment nor corrective/preventative action was required.The complaint for ¿delivery system ¿ difficulty with valve alignment ¿ unable¿ was confirmed.No manufacturing non-conformances were identified during the evaluation.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (valve alignment in non-straight section of anatomy may have contributed to the reported event.No labeling or ifu inadequacies have been identified and review of the complaint history revealed that the occurrence rates do not exceed the trigger for additional review.Therefore, neither a risk assessment nor corrective/preventative action was required.
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