EDWARDS LIFESCIENCES SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number 9750TFX26 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 03/27/2024 |
Event Type
Injury
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Event Description
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As reported by an edwards united kingdom affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra transcatheter heart valve, the valve was successfully implanted.However, as the operator progressed to the percutaneous coronary intervention to the left main artery, the operator engaged with the left coronary artery, and the patient had a stroke.The patient presented with right sided weakness (arm and leg) that were not responding to commands.The stroke team was contacted, and the patient began to recover from the symptoms prior to the end of the procedure.The patient was in stable condition.Per report, the perceived root cause of the event was a heavily calcified valve, which was recognized as a possible complication following the tavr procedure.The patient was known to have a history of a previous stroke.
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Manufacturer Narrative
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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 thv devices.According to the literature review, and as documented in a clinical technical summary written by ew, 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 most 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 significant differences in the frequency of late strokes between thv and avr patients.After thv, there appears to be a more considerable 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 suggest/indicate patient and procedural factors (heavy calcification) 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.
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Manufacturer Narrative
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Correction to b5 and h6 based on additional information.
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Event Description
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It was initially reported by an edwards united kingdom affiliate, that during a transfemoral tavr procedure with a 26mm sapien 3 ultra transcatheter heart valve, the valve was successfully implanted.However, as the operator progressed to the percutaneous coronary intervention to the left main artery, the operator engaged with the left coronary artery, and the patient had a stroke.The patient presented with right sided weakness (arm and leg) that were not responding to commands.The stroke team was contacted, and the patient began to recover from the symptoms prior to the end of the procedure.The patient was in stable condition.Per report, the perceived root cause of the event was a heavily calcified valve, which was recognized as a possible complication following the tavr procedure.The patient was known to have a history of a previous stroke.Per additional information received, the patient underwent a successful thrombectomy.
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