Catalog Number 1070275-38 |
Device Problems
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 05/25/2023 |
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 to a moderately calcified, mildly tortuous right coronary artery that is 75% stenosed.The 2.75x38mm xience xpedition stent delivery system was not able to advance as the shaft separated.A new xience xpedition stent was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.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.D9 - device available for evaluation: updated from yes to no.
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Search Alerts/Recalls
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