STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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Model Number M0035473060 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neuropathy (1983); Cerebral Edema (4403)
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Event Date 05/23/2023 |
Event Type
Injury
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Event Description
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It was reported that during an endovascular procedure for a ruptured aneurysm, physician used the subject coil and flow diverting stent to treat the patient.Post procedure on (b)(6) 2023, patient was readmitted due to fine motor disturbance of right hand since (b)(6), facialis weakness on right hand.Multifocal subcortical edema was notice in the ct (computed tomography) and mri (magnetic resonance imaging).According the physician it is caused by contact allergy (new) type iv to nickel + cobalt.No additional information available.
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Manufacturer Narrative
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This is the 2 of 3 mdrs.The device remains implanted inside the patient's vasculature.
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Manufacturer Narrative
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This is 2 of 3 mdrs.H4 manufacturing date ¿ added, d4 expiration date ¿ added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint of patient complications and patient neurological deficit.
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Event Description
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It was reported that during an endovascular procedure for a ruptured aneurysm, physician used the subject coil and flow diverting stent to treat the patient.Post procedure on (b)(6) 2023, patient was readmitted due to fine motor disturbance of right hand since (b)(6) may, facialis weakness on right hand.Multifocal subcortical edema was notice in the ct (computed tomography) and mri (magnetic resonance imaging).According the the physician it is caused by contact allergy (new) type iv to nickel + cobalt.No additional information available.
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Search Alerts/Recalls
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