The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device reveled that the stent was partially deployed from the distal end of the catheter and the stabilizer was observed to be deformed.During functional testing, the catheter was flushed, blood was noted within the delivery catheter and on the deployed stent.The friction was experienced in advancing the stabilizer through the catheter.Blood within the delivery system is an indication of insufficient flush, however this cannot be definitively determined.It is probable that the blood within the delivery system caused the as reported difficulty to deploy the stent and the as analyzed defects.Therefore, an assignable cause of procedural factors will be assigned to the as reported event and analyzed anomalies, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device direction for use(dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.
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