As reported through the japanese tavi registry, after a transfemoral tavr procedure with a 26mm sapien 3 valve in the aortic position, on post operative day (pod) 1, a cerebral infarction was observed, and diplopia occurred.Per the medical opinion, the event was procedure related and not device related.The seriousness was reported as serious because prolonged hospitalization was required.The outcome was determined as not recovered.
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A correction supplemental mdr is being submitted for engineering evaluation findings.Sections g6, h2 and h10 has been updated.Per the instructions for use (ifu), permanent or transient neurological events such as transient ischemic attack (tia) and stroke are known potential adverse events associated with the thv procedure and the use of the edwards transcatheter heart valve (thv) devices.According to the literature review, and as documented in a clinical technical summary written by edwards lifesciences, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing thv.Risk factors correlating with several patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during thv are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during thv demonstrated that the majority of procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no important differences in the frequency of late strokes between thv and aortic valve replacement (avr) patients.After thv, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but thv patients with multiple co-morbidities are probably at higher risk of both early and late strokes.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 could 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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