Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.As per the available information, the device deployed prematurely in the wrong location, too far distal.The physician tried to drag the stent back and the patient's blood pressure spiked and caused an aneurysm rupture.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the stent premature deployment, and it cannot be definitively determined if the stent premature deployment caused or contributed to the aneurysm rupture and patient complications, an assignable cause of undeterminable will be assigned to this complaint.
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