Catalog Number 1804250-33 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat the right coronary artery (rca) with moderate calcification and moderate tortuosity.The 2.5x33 mm xience skypoint stent delivery system (sds) failed to cross the lesion due to the anatomy and there was resistance with the anatomy during removal.A non-abbott stent was used 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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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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It was reported that the procedure was to treat the right coronary artery (rca) with moderate calcification and moderate tortuosity.The 2.5x33 mm xience skypoint stent delivery system (sds) failed to cross the lesion due to the anatomy and there was resistance with the anatomy during removal.A non-abbott stent was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported that the device was removed independently.No additional information was provided.
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Search Alerts/Recalls
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