Catalog Number 1070350-48 |
Device Problems
Material Separation (1562); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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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 left anterior descending (lad) artery with 100% stenosis and heavy calcification.The 3.5x48mm xience xpedition stent delivery system (sds) had resistance during advancement failing to cross due to the anatomy and the proximal shaft separated.The device was simply withdrawn and there was no resistance during removal.Another xience xpedition stent was used to complete the procedure.There was no adverse patient effect and there was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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A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.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 did not indicate a lot specific quality issue.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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