Model Number W5-3.5-2-MVI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Paralysis (1997); Vasoconstriction (2126); Speech Disorder (4415)
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Event Date 09/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint, that occurred during manufacturing of the device.The device was implanted in the patient and is not available to return to the manufacturer for analysis, and procedure images were not provided.Therefore, the alleged product issue cannot be confirmed.If additional information is received, microvention, inc.Will submit a supplemental report.The instructions for use (ifu) identifies vasospasm, headache, and neurologic deficits as potential complications associated with use of the device.
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Event Description
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It was reported that the web device was successfully implanted on (b)(6) 2022 to treat a subarachnoid hemorrhage (sah), anterior communicating artery (acom) aneurysm.During hospital stay, vasospasm on the left side occurred, which was treated with antispasmodics.The patient was discharged with light motoric aphasia.Reportedly, 1-2 weeks post procedure, the patient's condition worsened with progressive aphasia, right side hemiparesis, headache, and hypertonia.In the hospital, progressive cerebral enrichment was administered for suspected nice (non-ischemic cerebral enhancing).Treatment with methylprednisolone showed significant improvement.Currently, the patient's condition was described as progressive symptoms during lowering of the prednisolone dose.The patient is put on follow-up.
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Manufacturer Narrative
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Additional information received indicating no pre-existing conditions known which led to current patient condition.Unknown if patient was compliant with any dapt medicines post procedure.
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Manufacturer Narrative
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Additional information: h10 (image review).Four images were supplied.All four are from the same projection of an oblique left ica angiogram and are not dated.There are no measurements.Three are at different arterial phases of the subtracted dsa, and one has the superimposed bony background.They show a web in an occluded acom aneurysm; the web is adequately positioned.There are no images of the aneurysm before treatment.There are mild irregularities of the left a1, acom, and of the proximal bilateral a2s - these are in keeping with mild vasospasm secondary to the sah.There are no images that demonstrate the more severe vasospasm that is described to have occurred later on.The vasospasm on these images and the vasospasm that occurred subsequently are not related to the web procedure but rather to the sah, which is a known common cause of vasospasm.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused or contributed to the reported event.
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Search Alerts/Recalls
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