Model Number 213015-CAS-D |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2020 |
Event Type
malfunction
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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 implanted in the patient and the delivery system was not returned to the manufacturer for analysis.Intraprocedural or post-procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.
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Event Description
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It was reported that after deployment, the stent was not fully open at the proximal end.The stent was left implanted at the treatment site.There was no reported patient injury or additional intervention.
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Search Alerts/Recalls
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