As reported by our affiliate in (b)(6), during a mitral valve in valve procedure, a 26mm sapien 3 valve was deployed in a degenerated non-edwards surgical valve.During valve deployment, the commander delivery system balloon burst.The delivery system was able to be removed without the need for a cut down.No patient injury was reported.Following the removal of the delivery system, the valve was post dilated with a non-edwards balloon with good results.At the time of the report, the patient was doing well.Per medical opinion, the calcium at the left ventricle caused the rupture.
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Per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.The commander delivery system was not returned to edwards for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Case 3mesio review revealed calcification on the native annulus and pre-existing bioprosthetic valve.The device photographs indicated a longitudinal tear propagating to radial tear on the inflation balloon, and the distal section was inverted.Review of the cine image indicated the balloon was partially inflated when the burst occurred.Device history review (dhr) was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Transcatheter delivery balloon burst complaints have been previously investigated by edwards and as documented in a clinical technical summary written by edwards lifesciences.A detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus.Analysis revealed that these types of ruptures are typically caused by puncture from calcium on the native aortic valve when the inflated delivery system balloon comes in contact with the native annular calcification at full inflation/deployment.In this case, the complaint was confirmed based on the imagery and video provided.However, no manufacturing non-conformance was identified during the evaluation.Per reported notes, 'the calcium at the left ventricle caused the rupture'.Additional imagery review revealed, the patient had calcified native mitral valve with pre-existing valve.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) may have contributed to the complaint event.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.
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