Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was deployed and a post-implant balloon aortic valvuloplasty (bav) was performed.The balloon (20 true balloon) ruptured during the inflation and difficulty was encountered when the balloon was brought back into the introducer in the leg.When the introducer was removed, the balloon was no longer attached to the catheter.A surgical cut down was performed to remove the balloon from the external iliac artery.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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