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The commander delivery system was returned after use in the procedure fully inserted through an esheath and loader cap.A crimped thv was on the inflation balloon.The delivery system was locked at packaging position, with no fine adjust and ¼ flex used.The returned delivery system was visually inspected, and the following was observed: crimp balloon tear proximal to ic bond exposing inflation balloon wings which are flared outwards.Valve partially on inflation balloon.Portion of distal inflation balloon bunching against valve inflow struts. inflation balloon is damaged (torn) with tear that aligns with bunched balloon material against valve inflow struts and scuff marks present around region of tear.Damaged flex shaft, exposing underlying metal material, 3/4" proximal from flex tip.Flex tip gouges was observed and sheath soft tip damaged.Imagery was provided for review.The patient imagery observed tortuosity present in the iliacs and descending aorta and the access vessel is sufficiently sized with no/minimal calcification.The pre-operation ct showed a stent graft present on the aorta.Crimp balloon double wall thickness was measured along the edges of the torn location and inflation balloon single wall thickness was measured along the edges of the tear location.Measurements taken of the crimp and inflation balloon met specification.No relevant functional testing could be performed due to the nature of the complaint and condition of returned device (torn balloon).The complaint was confirmed through visual inspection.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no other complaints relating to the reported events.Regarding the reported event of a balloon tear and valve alignment difficulties, a complaint history review is not required as the issue has been previously identified in product risk assessment (pra) investigation, which captures root cause analysis for the issue.The pra discusses potential factors that can contribute to valve alignment difficulty (e.G.Induced tension in system), which in turn may subject the crimp balloon to high enough forces to result in component tearing.Regarding the reported event of the balloon leakage, a review of complaint history on confirmed device complaints (returned and no product returned) from august 2019 to july 2020 revealed similar events for the commander delivery system (all models and sizes).The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.In regarding to the reported withdrawal difficulties, a review of complaint history on confirmed device complaints (returned and no product returned) from august 2019 to july 2020 revealed similar events for the commander delivery system (all models and sizes).The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.Instructions for use (ifu), prepping manual, and procedure training manual were reviewed for instructions involving the commander preparation and procedure.Valve delivery: in a straight section of the vasculature, initiate valve alignment by disengaging the balloon lock and pulling the balloon catheter straight back until part of the warning marker is visible.Do not pull past the warning marker.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.System removal: caution: patient injury could occur if the delivery system is not unflexed prior to removal.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. 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: move to a different straight section of the aorta (for diving only).If using the balloon catheter, pushforward 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.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 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.Note: crimped thv aligned on balloon is larger than crimped thv off balloon.Take care if deciding to retrieve.Note: 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, the device is both visually inspected and tested several times throughout the process.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.The reported events for the balloon tear, balloon leakage, difficulty with valve alignment and withdrawal difficulty were confirmed based on visual inspection of the returned device.Investigation of the device and complaint history revealed no indication that a manufacturing nonconformance 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 events.A review of ifu/training materials revealed no deficiencies.Regarding the reported balloon tear (concerning crimp balloon damage) and difficulty with valve alignment: potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in product risk assessment (pra).If high tension is present in the system during alignment, it may have resulted in increased forces being applied to the bond area, causing crimp balloon damage.Potential sources of tension, as identified in the pra, include vascular tortuosity.As observed in patient imagery, marked tortuosity is present in the iliacs and abdominal aorta.Additionally, pre-operation ct reveals the presence of a stent graft in the straight section of the aorta (where valve alignment was presumably performed per case notes).Depending on the level of graft endothelization, the thv may have interacted with the graft during alignment, potentially resulting in further tension in the system.The presence of high tension in the system during valve alignment may result in difficulty performing the step and caused damage to the crimp balloon component.Severe flex tip gouges serve as evidence for high tension may have been present in the system during the valve alignment.While a definitive root cause is unable to be determined, available information suggests that patient/procedural factors (high tension resulting from vascular tortuosity and potential thv & stent graft interaction) may have contributed to the reported event.Regarding the reported withdrawal difficulty, as the crimp balloon is separated proximally to the ic bond, the balloon legs would have been exposed and more susceptible to catch on the sheath distal tip during delivery system retrieval.This may lead to the reported retrieval difficulty.The delivery system¿s balloon wings were flared out and lifted, indicating it may have been caught on the sheath distal tip.Additionally, vessel tortuosity may lead to noncoaxial retrieval of the delivery system, increasing likelihood the damaged delivery system getting caught on the sheath tip during retrieval.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (non-coaxial withdrawal/withdrawal of torn balloon) may have contributed to the reported event.Regarding the reported event of the balloon leakage (concerning inflation balloon damage): difficulties were noted during valve alignment and device retrieval.It is possible that excessive manipulation to troubleshoot the scenarios could have led to interaction between the thv and inflation balloon, resulting in observed damage/leakage.The balloon damage/leakage resulting from thv interaction is supported by the location of the damage (bunched balloon material against thv), and presence of scuff marks (potentially front thv struts) at the location of damage.Damage noted on the flex shaft, provides further support that the device may have been heavily manipulated.While a definitive root cause is unable to be determined, available information suggests that procedural factors (excessive manipulation during valve alignment or device retrieval) may have contributed to the reported event.In this case, the reported femoral artery injury was likely caused by device manipulation during withdrawal of the devices and/or patient factors may have contributed to the complaint event (tortuous access vessel and stent graft on aorta).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. regarding the balloon tear, since no confirmed edwards defect was identified in the evaluation, no preventative or corrective actions are required.Capa was previously initiated to incorporate existing information in training manual into the ifu documents.A pra was previously initiated to investigate the cause and assess the risk associated with balloon tear.The risks outlined in the pra remain the same.The pra documents the potential for ¿retrieval difficulty, resulting in peripheral surgical intervention¿, which did occur during this event.Pra has been initiated to establish a threshold for pra re-escalation (of note, complaint trending analysis in the complaint initiation month indicates complaint rates are within control).Prior compliance risk evaluation, health hazard assessment, and decisions/actions are the same and will remain unchanged.As there is no change in risk, the pra remains applicable and no further action is required.In regard to the withdrawal difficulty, valve alignment and balloon leakage, since no edwards defect was identified to have contributed to the complaint events, no corrective/preventative actions are required.Since no product non-conformances or labeling/training/ifu deficiencies were identified, a product risk assessment (pra) escalation is not required.
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