As reported by a field clinical specialist, during a tavr procedure with a 26mm sapien 3 ultra valve the 26mm commander delivery system balloon ruptured when the valve was about 80% deployed.A new 26mm delivery system was prepped and the valve was fully deployed successfully.There was no patient injury and the commander was discarded.Per the fcs, the team does not believe the device was deficient.The belief was the balloon ruptured from stj calcium burden (moderate calcium in the stj).The balloon was about 80-90% inflated when it burst.There was no added volume in the balloon.
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A supplemental mdr is being submitted due to additional information from a product investigation.The event reported is an 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.As device was not returned, engineering was unable to perform any visual, functional, 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.Per imagery review of the device, the balloon was burst longitudinally and radially.The complaint for balloon burst was confirmed based on the evaluation of the provided imagery.Available information suggests patient factors (calcification) likely contributed to the event as the event description stated, ''the belief was the balloon ruptured from stj calcium burden (moderate calcium in the stj)''.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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