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Catalog Number UNK EPIC PLUS |
Device Problems
Use of Device Problem (1670); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that on unknown dates, there were multiple complaints regarding epic plus mitral valves being unstable on the valve holder.It was reported that the valve would wobble or tilt slightly while the surgeon was implanting sutures, which made it more difficult for the sutures to be placed correctly.Additionally, the valve holder button used to remove the top part of the holder can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.If the top part of the holder is detached unintentionally, it can be difficult to reattach it because it must be oriented a particular way, which can be difficult in the middle of a procedure.There have not been any negative patient impacts reported.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on unknown dates, there were multiple complaints regarding epic plus mitral valves being unstable on the valve holder.It was reported that the valve would wobble or tilt slightly while the surgeon was implanting sutures, which made it more difficult for the sutures to be placed correctly.Additionally, the valve holder button used to remove the top part of the holder can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.If the top part of the holder is detached unintentionally, it can be difficult to reattach it because it must be oriented a particular way, which can be difficult in the middle of a procedure.The valve holder handle was also reported to be difficult to reattach if needed.There have not been any negative patient impacts reported.
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Manufacturer Narrative
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The valve being unstable on the holder was reported.Field indicated that the valve would wobble or tilt slightly while implanting sutures, making it more difficult for the sutures to be placed correctly.Additionally, it was also reported that the valve holder button used can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.It was difficult to reattach the holder in the middle of procedure because a specific orientation of the handle is required.No patient harm was reported.A returned device assessment could not be performed as the device was not returned for analysis.The epic plus design validation report and epic plus design validation protocol were reviewed to ensure that each manufacturing and inspection operation was performed and the product met all customer requirement specifications, including stability when placing the valve and holder release mechanism.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 medical device problem code: codes 1670 and 2907 removed.
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Search Alerts/Recalls
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