As reported, during a transfemoral transcatheter aortic valve replacement (tavr) with a 26mm sapien 3 ultra valve, the initial valve and delivery system punctured thru the esheath and became stuck.The entire system and sheath were removed as a unit.A new sheath, valve and delivery system were prepped and utilized.There was no harm done to the patient.A second valve was successfully implanted. the sheath was noted to be punctured. per pre deco evaluation, valve struts bent outwards was observed.
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The valve was returned stuck within the strain relief section of sheath.A review of imagery provided showed patient's access vessels had tortuosity.The returned devices were visually inspected for any abnormalities and the following observations were made: one (1) strut bent outward at the valve inflow side.All struts exposed through the skirt, normal after crimping and use.Post-expanded valve: one (1) strut remained slightly bent outward at the inflow by c3.Frame was distorted.Leaflets were wrinkled and dehydrated due to storage condition (prolong crimped duration) during the return handling process.All struts remained exposed through the skirt, normal after crimping and use.Sheath puncture, approximately 1.75 inches from distal end of strain relief.Minor gouges present on flex tip.No functional or dimensional testing was able to be performed due to device return condition.During manufacturing, all sapien 3 ultra valves are 100% visually inspected by both manufacturing and quality for any defects.Prior to final packaging, 100% visual inspection is performed at preliminary packaging.These manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the complaint event.A device history review (dhr) 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 additional similar complaints relating to frame damaged during use.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.A review of the risk management documentation was performed, and 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 frame damaged during use was confirmed from the evaluation of the returned valve.No potential manufacturing non-conformances were identified.A review of the lot history, dhr, and manufacturing mitigations did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.As reported, 'during a tf tavr with a 26mm s3u valve, the initial valve and delivery system punctured thru the esheath and became stuck.' additionally, per imagery, the patient's access vessel had tortuosity.The presence of tortuosity can create a challenging pathway during delivery system advancement, and it can lead to resistance and high push force.Per training manual, 'push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification', 'if push force is high, consider slightly pulling back the sheath 1- 2 cm while advancing the thv/delivery system', and 'do not over manipulate the sheath at any time'.In this case, it is possible difficulty was encountered during delivery system advancement so additional manipulation was applied to overcome the resistance as indicated by the gouges on the flex tip.So, if excessive force is applied to manipulate the device, it can lead to the valve struts catching and puncturing into the sheath shaft and resulted in the bent strut damage at the inflow.These patient/procedural conditions, in conjunction with the exposed apices of the crimped s3u thv, may increase the rate of frame damage.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (excessive device manipulation) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation and corrective/preventative correction (capa) are not required.Per management discretion, a product risk assessment escalation has been previously initiated to assess the risks associated with valve frame damage resulting from high push force of the commander delivery system with s3u through the esheath.A capa has been initiated to investigate issues associated with insertion of the valve through the sheath using the sapien 3 ultra system (sapien 3 ultra thv, commander delivery system, and esheath).
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