Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Extravasation (1842)
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Event Date 06/12/2012 |
Event Type
Death
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Manufacturer Narrative
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The subject device is not available.
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Event Description
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It was reported in a post market surveillance report that thrombectomy with the retriever was performed in the basilar artery and left ventricular artery.It was found that (b)(6) stenosis remained in the left ventricular artery after 1 pass.A non stryker stent was placed as treatment.Some clot remained in the terminus of the basilar artery, so angioplasty with the subject device was performed.Extravasation was noticed after the angioplasty.The patient passed away due to the extravasation.
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Manufacturer Narrative
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Outcomes attributed to ae: removed "required medical intervention to prevent permanent impairment/damage (device)".The device history record review could not be performed because the lot number of the device is not known.The device was not returned for analysis therefore visual inspection and functional testing could not be performed.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Patient hemorrhage and death are known and anticipated complications to these types of procedures and are noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.
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Event Description
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It was reported in a post market surveillance report that thrombectomy with the retriever was performed in the basilar artery and left ventricular artery.It was found that 95% stenosis remained in the left ventricular artery after 1 pass.A non stryker stent was placed as treatment.Some clot remained in the terminus of the basilar artery, so angioplasty with the subject device was performed.Extravasation was noticed after the angioplasty.The patient passed away due to the extravasation.
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Search Alerts/Recalls
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