Model Number MV-F501927 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
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Patient Problems
Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformance associated with this 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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.
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Event Description
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It was reported that upon deployment of the fred device to treat an aneurysm in the right internal carotid artery (ica), the device reportedly partially expanded.A balloon catheter was deployed to successfully expand the stent completely, which resulted in good flow through the stent.There was no reported patient injury.
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Manufacturer Narrative
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It was reported that the fred stent previously implanted in the patient was, on (b)(6) 2021, confirmed to have in-stent thrombosis when dsa was performed for a post-procedure follow-up.The patient is being observed and dapt with aspirin and clopidogrel was administered.The patient's condition was reported to be "not serious.".
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Search Alerts/Recalls
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