MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number EVOLUTR-23 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: upon receipt at medtronic¿s quality laboratory, all leaflets of the valve were flexible and intact.The leaflets were slightly twisted, in the closed position with gaps between the free margins of l1 and l3 as well as between l2 and l3.All commissures were intact.Bends were observed on the multiple cells of the frame.The frame of one paddle was broken.Conclusion: the device history record for (b)(4) and associated frame lot was reviewed and showed that this device met all manufacturing specifications for final product released for distribution.No issues were identified that would have impacted this event.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the evolut inst ructions for use (ifu), contains instructions to use the integrated loading bath which features a mirror to aid in loading of the valve.The user is instructed to not advance the capsule over the frame paddles unless they are fully seated in the center of the paddle pockets in order to avoid damage to the capsule and to avoid emboli.The damage is suggestive of possible frame misalignment during loading.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.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 prior to the implant of this transcatheter bioprosthetic valve, the valve was loaded onto the de livery catheter system (dcs) and appeared to be sheathed properly until a loud, audible "snap" was heard as the last third of the valve was sheathed.The end of the dcs was discolored and when the valve was unsheathed, a paddle on the valve frame had completely snapped off.A new valve was loaded onto a new dcs and successfully implanted.No adverse patient effects were reported.
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