Catalog Number 1804350-23 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
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 located in the distal left anterior descending coronary artery that was both moderately calcified and tortuous and 90% stenosed.The 3.5x23mm xience skypoint stent delivery system (sds) failed to cross the lesion and the tip of the device became bent.There was also resistance during removal of the sds.A new xience stent was implanted to complete the procedure.There were no adverse patient effects and there was no reported 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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