Per the instructions for use (ifu), permanent or transient neurological events including stroke are potential adverse events associated with the tavr procedure and the use of the edwards thv devices.According to 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 tavr.Risk factors correlating with a number of patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during tavr are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during tavr 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 tavr and avr patients.After tavr, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but tavr 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 device malfunction contributed to this adverse event.With the limited information provided, the cause of the stroke post sapien 3 ultra valve deployment.Investigation results suggest/indicate in addition to the procedure itself, patient factors not provided may have a contributed to the reported event.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Reference for article: moriyama n, lehtola h, miyashita h, piuhola j, niemelä m, laine m.Hemodynamic comparison of transcatheter aortic valve replacement with the sapien 3 ultra versus sapien 3: the homosapien registry.Catheter cardiovasc interv.2020 sep 23.Doi: 10.1002/ccd.29281.Epub ahead of print.Pmid: 32966682.Https://pubmed.Ncbi.Nlm.Nih.Gov/32966682/.This is one of ten manufacturer reports being submitted for this case.
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As reported by our affiliate in finland and through an article, ¿hemodynamic comparison of transcatheter aortic valve replacement with the sapien 3 ultra versus sapien 3: the homosapien registry¿.Data from the homosapien registry, from june 2017 to november 2019, indicated 141 patients underwent a sapien 3 valve implantation and 141 patients underwent a sapien 3 ultra valve implantation.From these patients, stroke occurred in 2 patients post sapien 3 ultra valve deployment.
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