MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number ENVEOR-N |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Vascular System (Circulation), Impaired (2572)
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Event Date 05/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the delivery catheter system (dcs) was not returned; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that immediately following the implant of this transcatheter bioprosthetic valve, an occlusion due to right external iliac artery dissection was reported via angiogram.A 8x10 millimeter (mm) stent was implanted from the right external iliac artery to the common iliac artery.It was confirmed that blood flow of the lower extremities was good, and the procedure was completed.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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