The filter dilator, curved pusher, sheath and cartridge were returned.The filter was not in the sheath or the cartridge.The pusher was inserted through the filter in the jugular direction, opposite of the indicated deployment direction.The sheath was found with a strip of complete delamination about 4 inches long extending out the distal end.The filter appeared to have a regular shape.A small string of material was found on one of the legs of filter.The device is undergoing an evaluation but has not yet been completed.A follow-up report will be submitted upon completion of the investigation.
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The filter dilator, curved pusher, sheath and cartridge were returned.The filter was not in the sheath or the cartridge.The pusher was inserted through the filter in the jugular direction, opposite of the indicated deployment direction.The sheath was found with a strip of complete delamination about 4 inches long extending out the distal end.The filter appeared to have a regular shape.A small string of material was found on one of the legs of filter.The part of the lining that was found outside of the sheath at the beginning of the product review appeared to be from the top of the sheath near the hub.A definitive root cause for this issue could not be determined.Somehow the sheath lining was damaged as the filter was advanced out of the cartridge.This appears to have occurred early and the lining appears to have inverted and followed the filter through the sheath and out the tip.From the images, the filter may have been encased in the inverted sheath lining outside of the sheath tip.Retrieval likely pulled the filter from the inverted lining, leaving it behind still attached to the sheath.What caused the initial sheath lining damaged is not clear.It may have been caused by interaction with the filter hook.Additionally, the inconsistency between the direction of the filter cartridge on the pusher and the reports that the filter was deployed from the femoral direction make it difficult to determine a definitive root cause.This type of delamination that inverts and encases the filter has not been observed previously.
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