Model Number RAD-SC30-175 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 08/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.The stealth peripheral orbital atherectomy system instructions for use manual states that dissection is a potential adverse event that may occur and/or require intervention.(b)(4).
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Event Description
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The target lesion was in the superficial femoral artery (sfa) and was 100% stenosed.Six treatment passes were performed with a peripheral stealth radial orbital atherectomy device (oad) on medium and high speeds.Balloon angioplasty dilatation was then performed, however significant residual stenosis remained.A shorter balloon at high pressure was then used to perform dilatation in the mid sfa, following which a type c dissection was noted.The balloon was inflated in place and access was gained to the posterior tibial artery.A sheath was inserted and a stent was delivered.The balloon was then used to dilate the stent.The final angiogram showed excellent flow and the patient was discharged the same day.
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Manufacturer Narrative
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Per the opinion of the treating physician, the reported dissection was caused by the balloon dilatation and no csi device caused or contributed to the event.Based on this information, this no longer meets the definition of a csi reportable event.(b)(4).
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Search Alerts/Recalls
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