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There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject retriever was seen to be slightly kinked/bent.The retriever shaped section was seen to have procedural fluid present.The insertion tool was not returned.The functional inspection was not required.The reported event is covered in the device directions for use (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 reported patient neurological deficit could not be confirmed during analysis as this is a patient related issue.The device failed to meet specification when received based on the anomalies noted.It was reported that a direct aspiration, first pass technique (adapt) was performed with the catheter for internal carotid artery (ica) c2 thrombus; however, the distal tip of the aspiration catheter was stuck and seemed the shaft was stretched.The aspiration catheter was removed from the body, and the sheath was cut, then inserted the aspiration catheter into the guiding sheath.However, the aspiration catheter became withdrawn from the target site by itself.Recanalization was achieved using catheters and retriever.However, postoperative computed tomography (ct) revealed a hyperintense area in the left mca.Given the high likelihood of metallic residue based on the circumstances, investigation requesting that the retriever device used in this case also be investigated.The additional information indicates that the paralysis was noted after the procedure due to the reported event with device.And the paralysis remains
the device was returned and there was some slight deformation noted to the retriever shaped section and there was evidence of thrombus on the retriever.These anomalies are evidence of typical use of the device.An assignable cause of procedural factor will be assigned to the analyzed "retriever shaped section damage", 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.The risk of patient neurological deficit is documented as an anticipated risk as part of these procedures in the product instructions for use, and it cannot be determined if the clinical procedure caused or contributed to the reported event, or if it related to the patient's presenting condition.There is no allegation of failure or malfunction against the retriever.An assignable cause of anticipated procedural complication will be assigned to the reported 'patient neurological deficit', as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
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