Model Number SR-0930-CS |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product associated with this complaint was returned to the manufacturer for analysis.The distal tip was not returned for analysis.Nevertheless, per microscopic analysis, scanning electron microscopy (sem) tests results showed that the separated area of the inner shaft of the unit presented evidence of elongations and cup and cone shape-like.Braid wires on the inner shaft presented evidence of plastic deformation, diameter reduction and ductile dimples on their surface.The previously mentioned damages are commonly associated with separations caused by material tensile overload.The cause of the material separation observed on the inner shaft, the bent condition of the body/shaft of the catheter, and the partial deployment of the stent could not be conclusively determined during the analysis.The reported failure is not related to the manufacturing process of the unit.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported a follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
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Event Description
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It was reported that during a trans-carotid artery revascularization (tcar) procedure, the stent would not pass through the lesion.While pulling the stent back, the distal tip of the stent delivery system came off, and remained in the carotid artery.The physician made the decision to convert the procedure to a carotid endarterectomy (cea), and successfully removed the marker, and the carotid was fixed.There was no report of patient harm.
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Search Alerts/Recalls
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