As reported by an edwards singapore affiliate, during a transfemoral valve in valve tmvr procedure with a 23mm sapien 3 valve in a non-edwards surgical valve, post implant echo showed pericardial effusion.The patient had to be drained through open sternotomy.Per report, it was suspected that the pericardial effusion was caused by a left ventricle wire perforation.The patient recovered and was extubated and discharged.
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Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures, annular tear, or rupture are known potential risks or 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 oversizing, 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 cardiovascular 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.Pericardial effusion is an abnormal accumulation of fluid in the pericardial cavity.Because of the limited amount of space in the pericardial cavity, fluid accumulation will lead to an increased intra pericardial pressure which can negatively affect heart function.When there is a pericardial effusion with enough pressure to adversely affect heart function, this is called cardiac tamponade.It can be caused by a variety of local and systemic disorders, or it may be idiopathic.Pericardial effusions can be acute or chronic, and the time course of development has a great impact on the patient's symptoms.In thv patients, it may be caused by guidewire perforations or annular ruptures.In transapical patients, postoperative pericardial effusions are common, most will resolve spontaneously, and some may require intervention.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate procedural factors 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.No corrective or preventative actions are required.
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