H4: manufacturing date: added.H3: device evaluated by mfg updated.H3: summary attached: updated.D4: expiration date: added.Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the returned stent was found to be deployed and not returned, the stent stabilizer was found to be kinked/bent, the stent delivery catheter was found to be kinked/bent, and the stent delivery catheter was found to be deformed.A functional test for the reported ¿stent failed/unable to deploy¿ was unable to perform as the stent was found to be deployed and not returned.While the reported complaint was not confirmed, the findings are consistent with the reported event.The device failed to meet specification when returned for device analysis.The reported event is covered in the device dfu.As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The device was returned and it was found that the stent was deployed from the device on return, the stent stabilizer was kinked/bent, the stent delivery catheter was kinked/bent and also the stent delivery catheter was deformed.It is probable that the anatomical or procedural factors present during the clinical procedure contributed to the reported event.An assignable cause of procedural factors will be assigned to the reported ¿stent failed/unable to deploy¿, ¿patient stroke¿, ¿patient complication¿ and ¿patient abnormal image finding¿ and to the analyzed ¿stent deployed prematurely during use¿, ¿stent stabilizer kinked/bent¿, ¿stent delivery catheter kinked/bent¿, and ¿stent delivery catheter deformed¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
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