It was reported that during the procedure to treat subarachnoid hemorrhage, the coil (subject device) got stretched and detached prematurely at the aorta artery.The physician attempted to remove the coil with a snare device, but was unsuccessful.It was reported that the patient passed away after the procedure due to brain swelling caused by thrombogenic progression and spasm developed due to the preexisting subarachnoid hemorrhage.
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It was reported that during the procedure to treat subarachnoid hemorrhage, the coil (subject device) got stretched and detached prematurely at the aorta artery.The physician attempted to remove the coil with a snare device, but was unsuccessful.It was reported that the patient passed away after the procedure due to brain swelling caused by thrombogenic progression and spasm developed due to the preexisting subarachnoid hemorrhage.
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H4 manufacturing date: added.D4 expiration date: added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that the patient had subarachnoid hemorrhage (sah) before starting the procedure, and the blood vessels had a lot of thrombogenic progression and spasm.The patient's blood vessels were very long and tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported.H3 other text : device not returned for evaluation.
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