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As reported, during a tf tavr case on a patient with severe as, the plan was to place a 26mm s3 ultra with a commander delivery system.The patient had tight iliac arteries, tortuous and calcified aorta throughout.The 14f esheath was inserted after much dilatation.It was difficult to navigate the commander delivery system through the sheath and tortuous anatomy of the aorta for alignment.After navigating the valve to the aorta to begin alignment, significant tension/tortuosity made it difficult to fine adjust the balloon into the valve.Additionally, there was great difficulty getting the valve to align with patient's anatomy.The was suspicion of balloon laceration during alignment, as negative was pulled on the inflation device and blood came back proving the balloon was compromised.The physician attempted to pull the valve back in to the esheath and withdraw the devices.The tortuous anatomy prevented the valve from returning into the sheath and would not withdraw below the iliac bifurcation.The decision was made for a vascular surgeon to cut down and surgically retrieve the valve.The valve was successfully removed after cutdown, but the ivc was lacerated and unable to be repaired.No device malfunction suspected, patient anatomical challenges.The patient expired as a result of ivc laceration and blood loss.
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Reference related voluntary medwatch report numbers mw5095830 and mw5095812.The commander delivery system was not returned to edwards lifesciences for evaluation.Imagery was provided by the field.The patient¿s vessels were observed to be undersized and have significant tortuosity through the vasculature.Based on empirical evidence via the imagery provided, the events can be confirmed.A dhr review was performed and did not reveal any manufacturing related issues that would have contributed to the complaints.A lot history review was performed and revealed no other complaints from the same work order with similar reported events.A review of complaint history on confirmed device complaints from august 2019 through july 2020 was performed.The complaints were reviewed based on similar reported events and associated root causes and evaluation codes.Of those complaints that were confirmed, the events were found to be related to patient factors and procedural factors.The ifu, prepping manual, and procedure training manual were reviewed for instructions involving the commander preparation and procedure.During delivery system insertion, check that the delivery system is locked in the default position and the edwards logo is up.Insert the loader completely into the sheath until it stops.Ensure the wire is still in lv and the sheath tip is still past the aortic bifurcation (above the renal arteries).Advance the thv through loader and sheath using short movements.For longer, peel away loader, retract and peel away.Keep the loader inserted in sheath until just prior to delivery system removal if using the shorter non-peel away loader.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.Rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock.Check the delivery system before 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.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.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, for diving, 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.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 thv can be retrieved through sheath only before thv deployment (still crimped).To do so, ensure the thv is centered on the flex tip and the delivery system is locked.Verify the flex catheter is completely unflexed.Retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip.Ensure the edwards logo on the sheath handle is facing upward.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.Crimped thv aligned on balloon is larger than crimped thv off balloon.Take care if deciding to retrieve.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.Retrievability is based on preclinical testing.No ifu/training deficiencies were identified.During manufacturing of the commander 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-conformance contributed to the reported events.The events were confirmed based on empirical evidence.However, since the device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be determined.However, a review of lot history, complaint history, and dhr, did not provide any indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint event.A review of ifu/training materials revealed no deficiencies.A review of similar complaints suggests that tortuosity can contribute to the events related to difficulty with valve alignment, torn balloon, and fine adjust difficulty reported in this complaint.Tortuosity was present throughout the patient vasculature.Tortuosity may result in increased valve alignment forces.If the user performed valve alignment at a bend/angle or in a tortuous vasculature, 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 higher than usual valve alignment forces and can create tension in the system to achieve final alignment position.As per complaint description, ¿after navigating the valve to the aorta to begin alignment, so much tension/tortuosity made it difficult to fine adjust the balloon into the valve.Additionally, there was great difficulty getting the valve to align with patient's anatomy¿.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 product 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 section 6, 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 (high tension due to valve alignment in non-straight section of anatomy) may have contributed to the reported event.It is possible that during withdrawal of torn balloon, balloon wings would have exposed and more susceptible to catch on the sheath distal tip causing the reported retrieval difficulty.Additionally, it is possible that tortuosity may have resulted in non-coaxial withdrawal of the delivery system into the sheath, further contributing to the reported difficulty.The cause of the reported ¿ivc laceration¿ that reportedly resulted in the patients demise is unknown as additional information was requested but not forthcoming.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.Since no confirmed defect was identified related to the withdrawal, valve alignment, and fine adjustment difficulties, no preventative or corrective actions are required.Additionally, since no product non-conformance or labeling/training/ifu deficiencies were identified, a product risk assessment (pra) escalation is not required.No confirmed defect was identified in the evaluation related to the torn balloon, so no preventative or corrective actions are required; however, a capa was previously initiated to incorporate existing information in the training manual into the ifu documents instructing the user to perform valve alignment in a straight section of the aorta to mitigate the risk of increased forces being applied.The capa was closed september 2019 after meeting the acceptance criteria of complaint rates remaining within complaint trending control limits.While this event occurred after capa completion, complaint rates remain within trending control limits.
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