STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 18 MICROCATHETER 150CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Catalog Number 90238 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hematoma (1884); Vasoconstriction (2126); Perforation of Vessels (2135); Rupture (2208); Obstruction/Occlusion (2422); Thromboembolism (2654); Vascular Dissection (3160)
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Event Date 11/04/2021 |
Event Type
Injury
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Event Description
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57 endovascular neurosurgeons, 78 interventional cardiologists, 6 interventional neurologists, 9 interventional neuroradiologists, and 36 interventional radiologists participated in the post-market clinical follow-up (pmcf) anonymous survey for subject trevo pro 18 microcatheter.The survey was conducted in (b)(6) and united states.During the survey hemorrhagic complication, re-occlusion, vessel dissection, clot embolization, neurological deficits, aneurysm recurrence, vessel perforation, stroke/tia, vasospasm, and groin hematoma were reported.No other information is available about this event.
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Manufacturer Narrative
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This is the 2nd of 6 reports.Subject device not returned.
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Event Description
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57 endovascular neurosurgeons, 78 interventional cardiologists, 6 interventional neurologists, 9 interventional neuroradiologists, and 36 interventional radiologists participated in the post-market clinical follow-up (pmcf) anonymous survey for subject trevo pro 18 microcatheter.The survey was conducted in australia, france, germany, italy, japan, spain, united kingdom and united states.During the survey hemorrhagic complication, re-occlusion, vessel dissection, clot embolization, neurological deficits, aneurysm recurrence, vessel perforation, stroke/tia, vasospasm, and groin hematoma were reported.No other information is available about this event.
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Manufacturer Narrative
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Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional testing could not be performed since the product was not returned as this complaint refers to a pmcf survey.The reported events are covered in the device directions for use (dfu).As well, the risk of the reported events are documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.While there are a number of potential causes for the reported issues, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
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Search Alerts/Recalls
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