Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned with an xt-27 microcatheter.Visual inspection was performed on the returned device and it was observed that the distal 6cm section of the returned xt-27 microcatheter was broken/fractured and flattening/crushing noted to the distal 15cm of the microcatheter.During functional testing, a patency mandrel was advanced through the returned xt-27 and the surpass evolve flow diverter was removed from the microcatheter.The surpass evolve flow diverter was found to be deployed and deformed within the xt-27 microcatheter lumen.The reported event was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.It is probable that the xt-27 microcatheter was damaged during the clinical procedure causing difficulties in deploying the flow diverter and causing premature deployment of the flow diverter within the xt-27 during the attempt to remove from the patient.An assignable cause of caused by other will be assigned to the reported and analyzed issues.The neurovascular stryker surpass evolve device is not currently approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.This is the first of 2 reports.
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