Catalog Number 1804250-38 |
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 12/15/2023 |
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 performed to treat a lesion in the mid left anterior descending (mlad) coronary artery with heavy calcification, moderate tortuosity and 99% stenosis.The 2.5x38mm xience skypoint stent failed to cross the lesion due to patient anatomy.Resistance was noted with the lesion upon removal.There were no adverse patient effects and no 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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Event Description
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Subsequent to the initial report, additional information was provided, indicating that the procedure was completed using a non-abbott stent.No additional information was provided.
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Search Alerts/Recalls
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