As reported by medical affairs, a patient called claiming that on (b)(6) 2008 he had an unknown stent placed in the "left main carotid artery".An unknown coil was placed in an unknown area in the brain due to a cat scan in 2008 showing the re-development of the brain aneurysm".In (b)(6) 2008, the patient reports having "right arm issues and became aphasic" unsure if due to brain aneurysm.Treatment not obtained at time of call.On (b)(6) 2008, the patient reports that "my head started to bleed again" and as treatment had another unknown stent and coil placed.Unknown if patient was hospitalized at time of event.In (b)(6) 2008, the patient reports having two titanium clips placed on right side of brain for unknown reason, hospitalization unknown.No further information could be obtained at time of call, the patient claimed to be "reluctant to give any more information".
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Complaint conclusion: as reported by medical affairs, a patient called claiming that on (b)(6) 2008 he had an unknown stent placed in the ¿left main carotid artery¿.An unknown coil was placed in an unknown area in the brain due to a cat scan in 2008 showing the re-development of the brain aneurysm¿.In (b)(6) 2008, the patient reports having "right arm issues and became aphasic¿ unsure if due to brain aneurysm.Treatment not obtained at time of call.On (b)(6) 2008, the patient reports that ¿my head started to bleed again¿ and as treatment had another unknown stent and coil placed.Unknown if patient was hospitalized at time of event.In (b)(6) 2008, the patient reports having two titanium clips placed on right side of brain for unknown reason, hospitalization unknown.No further information could be obtained at time of call, the patient claimed to be ¿reluctant to give any more information".The product remains implanted in the patient and thus is not available for evaluation.Additionally, as the sterile lot number was not available, device history record review could not be performed.Aphasia and right arm weakness are symptoms of tia, is a well-known potential adverse event associated with the carotid stent implantation procedure.The event of the cerebral bleeding might be associated to the patient¿s medical history of brain aneurysm.There is no evidence that manufacturing issues contributed to the event.
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