As reported from our affiliates in mexico, this was a case with a 26mm sapien 3 valve in aortic position by transfemoral approach.During the procedure, the esheath was inserted without inconvenience, the guidewire placed as usual, and the coronary protection was performed.The sapien 3 valve was prepared, the delivery system was advanced through the sheath, and the valve was aligned properly.The sapien 3 valve started to expand in an hourglass shape but the valve started to move and the final position was too deep.As a result, there was a severe paravalvular leak on the raphe side.It was decided to implant a second valve.A second 26mm sapien 3 valve was implanted successfully within the first sapien 3 valve with minimum paravalvular leak, and mean gradient 3 mmhg.The patient was noted to be stable during all the procedure and was transfer to coronary unit with a good recovery.24 hours after the procedure, the patient presented a complete atrioventricular blockage that progressed from a right bundle branch block present before the procedure, and it was decided to implant a definitive pacemaker.As per medical opinion, the malposition of the first sapien 3 valve was due to the raphe's calcification since it was not able to expand the valve in the right position, causing that the valve was implanted too deep.The patient presented a bicuspid sievert 1 valve raphe between lcc and rcc with wide sinuses and moderate calcification, and unique left coronary artery with approximately 7 mm height from the annulus plane.Despite of this, patient rejected open-heart surgery and it was decided to perform a transcatheter valve replacement with a low implant and coronary protection with a guide catheter and a coronary stent.
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The device was not returned for evaluation as it remained implanted.The complaints for valve malposition and paravalvular leak were unable to be confirmed as no imagery /medical record were provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.As reported, "the sapien 3 valve started to expand in an hourglass shape, but the valve started to move, and the final position was too deep.As a result, there was a severe paravalvular leak on the raphe side.It was decided to implant a second valve." additionally, per the event description patient had a "bicuspid sievert 1 valve raphe between lcc and rcc with wide sinuses and moderate calcification." per provided medical opinion, "the malposition of the first s3 was due to the raphe's calcification since it was not able to expand the valve in the right position, causing that the valve was implanted too deep." per the instructions for use (ifu) , valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.In this case, patient had presence of calcified interleaflet raphe, which is defined as the conjoined area of two underdeveloped leaflets turning into a malformed commissure between both leaflets.The presence of this irregular feature likely impacted proper thv deployment via undesired interactions between the ds/balloon and the raphe (likely rigid in nature).This could have pushed the thv downward during inflation, causing it to land too ventricular.As such, available information suggests that patient factors (calcified interleaflet raphe) may have contributed to the valve malposition.Due to the valve malposition, wherein the valve was deployed too low, the pvl skirt was most likely unable to properly seal against target site, resulting in paravalvular leak (pvl).As such, available information suggests that procedural factors (thv malposition) may have contributed to the paravalvular leak.Per the instructions for use (ifu), conduction system defects (heart block), arrhythmias and conduction system defects that may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, bioprosthetic heart valves, and the thv procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may explain these complications of the thv procedure.According to the literature review, and as documented in ew clinical technical summary for complaints-conduction disturbances/ heart block, atrioventricular conduction disturbances after thv are associated with many patient-related and procedural related factors, including pre-operative co-morbid status, the degree, and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, thv may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after thv are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing thv or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that both patient and procedural factors could have 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 at this time.
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