Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a transcatheter heart valve (thv) procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive as patient and procedural factors were not provided; however, the event may be related to the mechanisms described above.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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As reported through edwards japan affiliate, after a transfemoral tavr procedure with a 23mm sapien 3 valve in the aortic position, post valve deployment the patient's blood pressure did not return well.Transesophageal echocardiogram (tee) revealed a pericardial effusion.A pericardiocentesis was performed and protamine was administrated.Although hemorrhage decreased, bleeding site was not identified.A little hemorrhage continued; midline incision was performed.Bleeding was from left ventricle (lv) and was pinhole shaped.The operator concluded that the lv perforation was caused by a guide wire perforation.The lv perforation was repaired surgically.Hemodynamics was stable during procedure.The patient was transferred to icu.
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