Update to h6; type of investigation, investigation findings, investigation conclusion.The commander delivery system (ds) was not returned to edwards lifesciences for evaluation; therefore, no visual inspection, functional testing, and dimensional testing are applicable.Imagery was provided that showed there was a radial and longitudinal tear burst at the distal should of the inflation balloon.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint for balloon burst was confirmed through the provided device picture.However, no manufacturing non-conformance was identified during the evaluation.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why the deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.As per follow-up information and 3mensio received, the patient has bulky calcification in the landing zone, and as per the medical opinion, the perceived root cause for the balloon burst was heavy calcium burden at the annulus and left ventricular outflow tract (lvot).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 the following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.In addition, the technical summary outlines the extensive manufacturing mitigation's 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 mitigation's are still in place.In this case, a review of available information suggests that patient factors (calcification) contributed to the balloon burst.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.No corrective or preventative actions are required.
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