Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that there was no damage noted to the packaging, the device was confirmed to be in good condition after unpacking, no anomalies were noted to the device prior to use, the device prepared as per the dfu, the stent delivery system was flushed with saline prior to use and the stent did not experience friction when moving the system over the guidewire.The microcatheter tip was not shaped and there was no damage noted to the microcatheter.During advancement or repositioning of the device, the inner body was not advanced independently of the outer body, continuous flush was maintained and there was no resistance encountered between the stent delivery system and the guide catheter as it was advanced to the lesion.The delivery catheter rhv was opened sufficiently to allow stent deployment.The patient¿s anatomy was severely tortuous on radial approach.The stent was advanced to the aneurysmal area, but when the physician attempted to reposition the stent, in both attempts, the stent came off the delivery system when advancing and retracting.There was no difficulty pulling back the outer body.The physician attempted to position the second stent into location when the stent again came off the delivery system.Fortunately, when this occurred the second time, the stent was optimally positioned and the physician made the decision to fully deploy the stent without repositioning.While the device was not returned, an assignable cause of procedural factors will be assigned to the reported event as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
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