Catalog Number M0036127200 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Thrombosis (2100); Dysphasia (2195)
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Event Date 04/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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The subject device remains implanted in the patient.
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Event Description
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It was reported during a stent assisted coiling of aneurysm at the middle cerebral artery(mca) branch, the coil(subject device) was repositioned and wrapped around the stent.The patient returned with an acute occlusion of the m2 branch due to in-stent thrombosis.The physician administered tpa (tissue plasminogen activator) and other medication to breakup the clot and restore blood flow, no other medical interventions were performed.It was reported the patient is stable however, patient was reported to have continued stoke symptoms and aphasia as a result of the event.No further information is available.
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Event Description
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It was reported during a stent assisted coiling of aneurysm at the middle cerebral artery(mca) branch, the coil(subject device) was repositioned and wrapped around the stent.The patient returned with an acute occlusion of the m2 branch due to in-stent thrombosis.The physician administered tpa (tissue plasminogen activator) and other medication to breakup the clot and restore blood flow, no other medical interventions were performed.It was reported the patient is stable however, patient was reported to have continued stoke symptoms and aphasia as a result of the event.No further information is available.
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Manufacturer Narrative
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Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Additional information provided by the customer indicated that anatomy was very tortuous.Therefore, this complaint appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural factors during use.
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Event Description
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It was reported during a stent assisted coiling of aneurysm at the middle cerebral artery(mca) branch, the coil(subject device) was repositioned and wrapped around the stent.The patient returned with an acute occlusion of the m2 branch due to in-stent thrombosis.The physician administered tpa (tissue plasminogen activator) and other medication to breakup the clot and restore blood flow, no other medical interventions were performed.It was reported the patient is stable however, patient was reported to have continued stoke symptoms and aphasia as a result of the event.No further information is available.
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Manufacturer Narrative
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H6 device code grid: updated.H10 additional mfg narrative: updated to include coil protrusion.Investigation was updated to included coil protrusion.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Based on the updated investigation findings, a cause of procedural factors has been assigned to this investigation.
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Search Alerts/Recalls
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