As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, contrast was observed during full inflation of the 26mm commander delivery system in the aorta, and aspirated in the inflation device, indicating that the balloon had ruptured.The commander delivery system was removed, and a longitudinal tear was observed by the operator beginning in the trailing end of the balloon, at the level of the sinotubular junction.The operator was aware of the presence of an eccentric, bulky calcification at the level of the sinotubular junction, which was the perceived root cause of the balloon rupture.
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The event(s) reported is/are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, available information suggests that patient factors (calcification) likely contributed to the event as the customer reported that there was 'presence of an eccentric, bulky calcification at the level of the sinotubular junction'.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst 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.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.
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