H10: 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.The stent sheath including stent was broken off and missing, in addition, the stability sheath was found broken and the diving sheath and the inner catheter were found kinked and broken.However, as the device was used during a product demonstration it is reasonably suggested that the condition of the sample is a result of additional manipulation during product demonstration.As the slide block inside the delivery system - a force transmitting component - was no longer connected to the proximal sheath, it is considered that the slide block getting disconnected, led to the initial impossibility to deploy the stent.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 definite root cause is not yet available.Labeling review: in reviewing the relevant labeling for this product, potential factors for increased deployment forces were found addressed.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." 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." regarding accessories to be used the instructions for use states: "the delivery system is compatible with 0.035 inch (0.89 mm) guidewires and 8f or 9f introducer sheaths." h10: 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.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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