EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number 9750TFX26A |
Device Problems
Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Retroperitoneal Hemorrhage (4483)
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Event Date 08/24/2021 |
Event Type
Death
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Event Description
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Upon positioning a deployment balloon inside the sapien - edwards valve for a planned transcatheter aortic valve intervention, it was noted that a stent strut on the leading edge of the valve had been bent backwards after delivery to the descending aorta.It was decided that the best course of action was to remove the valve system and replace with a new one.Immediately after the withdrawal of the valve and sheath the patient became hypotensive.A large tear in the external iliac artery was noted.Although contralateral balloon tamponade and massive transfusion was performed the patient succumbed to a massive retroperitoneal bleed.Fda safety report id # (b)(4).
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