Edwards received notification from our affiliate in france.As reported, it was an implant case of a 26mm sapien 3 ultra transcatheter heart valve implant in the aortic position by transfemoral approach.The patient had type 0 bicuspid aortic valve with heavy calcification on both cusps.During the procedure, right after valve deployment, the patients pressure dropped and an annular rupture was suspected.Drainage was initiated to prevent cardiac tamponade and a lot of blood was drained.Annular rupture was confirmed.The patient had a cardiac cardiorespiratory arrest and expired in the operating room.
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Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures, and hematoma are known potential adverse events associated with the overall thv procedure and may require intervention.According to the thv training manuals, risk factors for aortic dissection, hematoma, or annular rupture during the thv procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification, and narrow calcified stj.In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury.At times, the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve, and procedural success.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest that patient factors (annulus calcification) and procedural factors (valve deployment) caused or contributed to this 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 this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.
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