MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number ENVEOR-US |
Device Problems
Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: the product was discarded by the customer; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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 during the implant of this transcatheter bioprosthetic valve into a failed non-medtronic surgical aortic valve with aortic insufficiency, the capsule of the delivery catheter system (dcs) separated.The valve was loaded to an incompatible dcs size per physician request by an experienced loader with little resistance.The dcs was advanced through a 14 french sheath and tortuous anatomy.During deployment, tension was noted and the capsule opened 10mm prior to the separation.The dcs and valve were withdrawn from the body through a 20 french sheath.No adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The reported event indicated that the capsule broke during deployment.Typically, capsule break/separation occurred due to excessive compressive forces applied during the valve loading process.This excessive compressive force was experienced when the valve was loaded incorrectly.In this case, it was reported that the valve was loaded onto an incompatible dcs size per the physician's request.The evolut system instructions for use (ifu) outlined the system compatibility; the evolut pro valve is compatible with the 20 fr enveor-n-us dcs model only, rather than the 18 fr enveor-us model that was used in this case.It cannot be determined if the incompatible dcs size caused or contributed to the capsule break.There was no information to suggest a device quality deficiency may have caused or contributed to this event, but a conclusive root cause cannot be determined at this time.The dcs and valve were withdrawn from the body and no adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
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