CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Device Problem
Off-Label Use (1494)
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Patient Problems
Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Health effect - clinical code 4581: slow/no flow.The device history record for the reported oad could not be reviewed as the lot number was not provided.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).
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Event Description
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A stealth 360 peripheral orbital atherectomy device (oad) was used to treat the proximal superficial femoral artery (sfa) with a distal stent.The oad was advanced to the proximal edge of the stent, however, the oad was unable to be advanced through the stent.It was decided to spin the oad through the stent.This resulted in a distal embolism and slow flow of the sfa.Percutaneous transluminal angioplasty and manual aspiration were performed to resolve the event.The patient was stable.
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Search Alerts/Recalls
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