Catalog Number 1070250-48 |
Device Problems
Difficult to Remove (1528); 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 02/17/2023 |
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 to treat a lesion in the right coronary artery (rca) with moderate calcification and mild tortuosity.The 2.5x48mm xience xpedition stent delivery system (sds) had resistance and failed to cross due to the anatomy.The proximal shaft separated.There was resistance with the anatomy during removal, however, the separated portion was simply withdrawn.Another same sized xience xpedition stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay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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The device was returned for analysis.The reported material separation was confirmed.The reported failure to advance and difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.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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Search Alerts/Recalls
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