Catalog Number M003WE0350150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Weakness (1967); Dysphasia (2195)
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Event Date 01/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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This is report 2 of 2.Device remains implanted in patient.
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Event Description
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It was reported that the patient was stented for a long artery dissection on right ica (internal carotid artery) c2 segment.The stent (subject device) was implanted smoothly and the procedure was completed successfully without any difficulties.Post procedure, the patient showed good recovery of the dissection site.However, one week post procedure, the patient got complete aphasia and grade 1 on left upper limb of muscle strength and grade 0 on left lower limb of muscle strength.The patient received conventional antiplatelet and anti-infection treatment for aphasia and muscle strength weakness.Ten days post procedure, the patient left the hospital without receiving further treatment.No further information is available.
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Manufacturer Narrative
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The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Based on the investigation results and available information an assignable cause of anticipated procedural complication was assigned to the as reported issue of patient muscle weakness and dysphasia since the issues are due to known physiological effects of the procedure and or/ patient condition noted with the direction for use, device labelling and/or risk documentation files.
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Event Description
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It was reported that the patient was stented for a long artery dissection on right ica (internal carotid artery) c2 segment.The stent (subject device) was implanted smoothly and the procedure was completed successfully without any difficulties.Post procedure, the patient showed good recovery of the dissection site.However, one week post procedure, the patient got complete aphasia and grade 1 on left upper limb of muscle strength and grade 0 on left lower limb of muscle strength.The patient received conventional antiplatelet and anti-infection treatment for aphasia and muscle strength weakness.Ten days post procedure, the patient left the hospital without receiving further treatment.No further information is available.
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Search Alerts/Recalls
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