The patient was undergoing a thrombectomy procedure to treat an occlusion in the right m2.First, four passes were conducted with two sizes of stent retrievers and competitor's 5f and 6f aspiration catheters.After the four unsuccessful attempts to open the occlusion, a zoom 45 aspiration catheter was successfully used to remove the clot and flow was restored.The physician observed a vessel dissection during the routine contrast run performed post clot removal.A stent was then placed through the vessel and flow was confirmed.There were no device deficiencies reported.On (b)(6) 2022, the patient was discharged to rehab, and the stent was reportedly open.
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The device was discarded after use and therefore not available for return and investigation.No additional information could be obtained.There were no device deficiencies reported related to the zoom 45.Based on the information reported, four unsuccessful passes were made with competitor's devices before introduction of zoom 45.Zoom 45 was eventually used to restore the flow.Since limited information was provided about the case, the device was not returned for investigation, and limited case images provided, the relationship with zoom 45 to the dissection could not be established and it is not clear if the competitor's devices used earlier in the case could have caused or contributed to the dissection.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed prior to release to ensure the device met specifications.
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