Catalog Number 1011709-12 |
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 04/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat the heavily calcified, moderately tortuous left anterior descending (lad) coronary artery.The 3.0x12 mm xience prime stent delivery system (sds) failed to cross the lesion as the distal shaft separated during advancement.There were no adverse patient effects and there was no clinically significant delay in the procedure.Another device was used to complete 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 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 the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3- device return status changed from yes to no.
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Event Description
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It was reported that the procedure was to treat the heavily calcified, moderately tortuous left anterior descending (lad) coronary artery.The 3.0x12 mm xience prime stent delivery system (sds) failed to cross the lesion as the distal shaft separated during advancement.There were no adverse patient effects and there was no clinically significant delay in the procedure.Another device was used to complete the procedure.Subsequent to the initially filed report, it was reported that the proximal portion of the device was simply withdrawn.Additionally, the device was returned with a separated shaft but was only prepped.Follow-up was performed with the account and per the account the correct device was received.No additional information was provided.
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Search Alerts/Recalls
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