The catalog number identified has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent products are identified.Manufacturing review: the lot history record of this lot was 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 was not returned for evaluation and photos were not provided.Based on the information available, investigation is inconclusive for thrombosis/necrosis.A definite root cause of the reported incident cannot be identified based upon the available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risk.Based on the instructions for use, complications and adverse events associated with the use of the e-luminexx stent may include the usual complications associated with endovascular stent and covered stent placement which include "thrombosis at puncture site or remote site", "bleeding from anticoagulant or antiplatelet medications" and "embolization, distal (air, tissue or thrombotic emboli)".The instructions for use also states "the 6fr delivery system requires a minimum 6f introducer sheath.The delivery system has a soft and flexible catheter tip formed from the outer catheter.The catheter tip is tapered to accommodate a 0.035¿(0.89 mm) guidewire".The instructions for use further state: "after stent deployment, carefully withdraw the delivery system from the patient over the guidewire.After removing the delivery system, visually confirm that the entire stent delivery system has been removed.".
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