Model Number M0036125100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Obstruction/Occlusion (2422); Ischemia Stroke (4418)
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Event Date 12/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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The subject device is unavailable to manufacturer.
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Event Description
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It was reported that the patient had ischemic stroke post-procedure at the right mca(middle cerebral artery) bifurcation inferior division territory.Per progress note, small right-temporal infarction is likely attribute table to rapid thrombosis of the aneurysm and subsequent embolization, precipitated by profound postoperative hypertension.Heparin 8000 unit iv once was administered to the patient.The patient was treated with interventional radiology stroke therapy and injection of heparin 4000 units and 4mg ia tpa under fluoroscopy.The event of stroke is still ongoing.No other information was provided.
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Manufacturer Narrative
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B5 executive summary: updated - based on additional information received on (b)(6) 2022 that the stroke post procedure was caused by embolic occlusion of right mca branch.B6 relevant tests and lab data : updated.F10 / h6 health effect - clinical code - updated.
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Event Description
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It was reported that the patient had ischemic stroke post-procedure at the right mca(middle cerebral artery) bifurcation inferior division territory.Per progress note, small right-temporal infarction is likely attribute table to rapid thrombosis of the aneurysm and subsequent embolization, precipitated by profound postoperative hypertension.Heparin 8000 unit iv once was administered to the patient.The patient was treated with interventional radiology stroke therapy and injection of heparin 4000 units and 4mg ia tpa under fluoroscopy.The event of stroke is still ongoing.No other information was provided.Based on additional information received on 29-december-2022 that the patient stroke post procedure was caused by embolic occlusion of right mca branch.There were no any difficulties encountered during the procedure that could have contributed to the patient¿s stroke post procedure as the subject coil performed as intended.
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Manufacturer Narrative
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Section d catalog # search/gim search results/ product long description/ gim search results: corrected, section d lot #: corrected, h4 manufacturing date ¿ added, d4 expiration date ¿ added.Due to the automated manufacturing execution system (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 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.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.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.
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Event Description
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It was reported that the patient had ischemic stroke post-procedure at the right mca(middle cerebral artery) bifurcation inferior division territory.Per progress note, small right-temporal infarction is likely attribute table to rapid thrombosis of the aneurysm and subsequent embolization, precipitated by profound postoperative hypertension.Heparin 8000 unit iv once was administered to the patient.The patient was treated with interventional radiology stroke therapy and injection of heparin 4000 units and 4mg ia tpa under fluoroscopy.The event of stroke is still ongoing.No other information was provided.Update info: based on additional information received on 29-december-2022 that the patient stroke post procedure was caused by embolic occlusion of right mca branch.There were no any difficulties encountered during the procedure that could have contributed to the patient¿s stroke post procedure as the subject coil performed as intended.
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Search Alerts/Recalls
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