Catalog Number 1070300-48 |
Device Problems
Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with moderate calcification, moderate tortuosity and 85% stenosis.The 3.0x48 mm xience xpedition stent delivery system (sds) was advanced to the lesion and resistance with the anatomy was noted and the shaft of the delivery system broke.The guide wire was pulled back in order to remove the broken shaft.A new xience xpedition sds was used to complete the procedure.There were no adverse patient effects and there was no 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 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.H6: medical device problem code 2920 added.
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Search Alerts/Recalls
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