Exemption number e2016006, this report summarizes 5 events of ischemic stroke serious injury events for the sapien 3 in the mitral position.The ¿time to event¿ (tte, in days) for this event was.6.Per the instructions for use, permanent or transient neurological events including stroke are potential adverse events associated with invasive cardiac procedure including transcatheter heart valve procedures.According to literature review, and as documented in a clinical technical summary 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, the event may be related to the mechanism described above.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.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).
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(b)(6) registry alternative summary reporting (asr) adverse event submission for february 2020 data extract for mitral serious injuries for the sapien 3.February 2020 data extract includes data provided by acc for q3 2019 (july 1 - september 30). this report summarizes 5 events of ischemic stroke serious injury events for the sapien 3 for february 2020.The age range for these events are from 52 to 80.The breakdown for gender is as follows: 1 male, 3 females, and 1 unknown.
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