Catalog Number 1120350-28 |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
Injury
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Event Description
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It was reported that the procedure was to treat a 90% de novo lesion in the distal left anterior descending with heavy calcification and mild tortuosity.After pre-dilatation, the 3.5x28mm xience alpine stent delivery system (sds) was advanced, but met resistance and stuck with the lesion.When attempting to remove the sds, the stent dislodged from the balloon and remained in the vessel.A guideliner was introduced to remove the dislodged stent.A non-abbott stent was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay reported 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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Event Description
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Subsequent to the initial report being filed, it was reported that the dislodged stent was removed with the guideliner.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 and treatment 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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