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 09/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: no product was returned.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 four days following the implant of this transcatheter bioprosthetic valve, a dissection of the access blood vessels was observed with a subacute occlusion.A percutaneous transluminal angioplasty (pta) was performed.The minimum access vessel diameter was 6.5 mm.The injury wasn't noted until after the procedure.Per the physician, it is unknown what caused the injury.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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