As reported by an edwards lifesciences affiliate in australia, regarding an implant of a 23mm sapien 3 ultra valve in aortic position by transfemoral approach.During the procedure, when the 23mm commander delivery system balloon was in full inflation with +1cc and slow to medium technique, the balloon burst.The delivery system was removed through the esheath without difficulties.Another 23mm commander delivery system was prepared and the valve was post-dilated with +1 ml.The patient did not suffer any injury, and was noted as to be discharged 48h after the procedure.As per medical opinion, the root cause of the event was the calcific annulus.
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The event is 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.Imagery was provided by the site for review, and revealed the following: balloon longitudinal and radial burst and balloon burst upon inflation.The reported event was confirmed based on review of the provided imagery.Available information suggests patient factors (calcification) and/or procedural factors (over-inflation) likely contributed to the event as the description indicated presence of calcification in the annulus, and an additional plus 1cc of fluid was administered to the balloon.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.Additionally, while the prescribed nominal inflation volume is provided in the ifu, it is possible that extra inflation volume was used (over-inflation), subjecting the balloon to pressures high enough to cause the balloon to burst.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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