Catalog Number 1804400-12 |
Device Problems
Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a de novo lesion in the proximal left main artery with moderate calcification.The 4.0x12mm xience skypoint stent delivery system (sds) had resistance during advancement with the guide wire.Upon removal, the tip of the delivery system snagged on the guide wire and the tip separated falling off outside the anatomy.Another non-abbott stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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