The catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified in d2 and g4.Manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system of a covered stent was returned for evaluation.The slide block, a force transmitting component was no longer connected to the proximal sheath.The disconnection of the slide block is considered to have led to the reported impossibility to deploy the stent.The stent was found partially deployed upon sample receipt.No difficult patient anatomy was reported and device compatible accessories were used, and the lesion was pre dilated.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding the precautions prior to deployment, the instructions for use state: 'maintain a stationary hold on the white stability sheath during covered stent deployment.Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath relaxed and avoid tension.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation and accessories, the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." and "0.035-inch (0.89 mm) guidewire of appropriate length introducer sheath with appropriate inner diameter and length.".
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