(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.However, it may be possible that the distal sheath was restricted or entrapped within the anatomy such that when the sheath finally released, and the stent deployed, the stent jumped due to the built up tension within the shaft lumens of the delivery system causing a spring like release of the stent.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents reported from this lot.The investigation was unable to determine a cause for the reported inaccurate delivery.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a lesion located in the left iliac artery with no calcification and no tortuosity.Resistance was not felt during advancement of the 8.0 x 20 mm absolute pro stent delivery system (sds) and it crossed the lesion successfully; however, during deployment of the stent, the physician noted that the stent jumped forward slightly.Stent was deployed partially in health tissue; however, covered most the lesion therefore no additional stent was needed.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.
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