User facility medwatch report received that states "abbott emboshield nav6 embolic protection system detached in pt.Physician had to use snare device to remove detached portion from pt.Device given to dept mgr.Factual description per event summary, surgeon confirmed no harm or detrimental impact to pt regarding this device failure.Also, confirmed that device in its entirely was successfully removed.Physician indicated this is an isolated incident.He has done thousands of these procedure with this device.This is the first instance he has encountered.He also indicated that the pt's anatomy (angle of aortic bifurcation} necessitated a sharper turn through the aortic bifurcation while using the device.Physician believed this is a "oneoff" situation".Subsequent to receiving the user facility medwatch, the account confirmed the separation occurred during advancement.
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no indication of a lot specific product quality issue.It should be noted the emboshield nav6 embolic protection system electronic instructions for use warns: the emboshield nav6 device can only be used with the barewire filter delivery wire.Use of the device with any guide wire other than the barewire filter delivery wire will lead to loss of the filtration element during the procedure or an inability to retrieve the filtration element.In this case, it could not be determined if use of the non-abbott guide wire caused or contributed to the difficulty.Based on the information provided, the investigation was unable to determine a cause for the reported difficulties resulting in unexpected medical intervention to remove the separated portion of the delivery catheter pod.It may be possible that during advancing against resistance with the anatomy, damage to the delivery catheter pod occurred and when the attempt was made to deploy the filter the pod separated as a result of the damage causing the filter to partially deploy.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: additional information added.D9/h3: return status updated.D10: updated.E1: facility name and address updated.H6: medical device problem code 1494 removed, 2017 guide wire/fdw selection incorrect added, 3270 added.
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