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 delivery system was returned for evaluation in activated condition; the covered stent was found partially deployed; the force transmitting distal stent sheath was broken which indicates high tensile forces were experienced during deployment.It is considered the break of the distal stent sheath led to the impossibility to deploy the stent which leads to confirmed results for break and partial deployment.Based on evaluation of the sample, the investigation is closed with confirmed results for break and partial deployment.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 correct deployment the instructions for use states: "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." based on the instructions for use material required for a procedure using the covera vascular covered stent are (.) 0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter.Regarding preparation 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." (expiry date: 06/2024).
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