As reported by an edwards lifesciences affiliate, regarding a 26mm sapien 3 ultra valve in a pre-existing 29mm mosaic surgical valve in the aortic position.During valve deployment, the 26mm commander delivery system balloon ruptured during deployment before nominal volume could be reached (++1 was added to the balloon).The balloon was removed successfully through the 14f esheath plus.The patient is stable, and the valve was successfully implanted.
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The event reported 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.Imagery was provided for review and a balloon burst in a longitudinal and radial manner was observed.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.The reported event was confirmed based on the customer provided imagery.Available information suggests calcification likely contributed to the event as the valve was implanted in a failed surgical valve with calcified leaflets.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.The customer also reported, plus 1cc was added for inflation 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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