Catalog Number 1070300-48 |
Device Problems
Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
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 heavily calcified, moderately tortuous left anterior descending artery that is 70% stenosed.The lesion was pre-dilatated with a 2.5x50mm mini trek balloon dilatation catheter and a 3.0x48mm xience xpedition stent delivery system (sds) was attempted to advance; however, met resistance with the guiding catheter and met during removal with the guiding catheter.During removal the shaft separated.The separated portion was retrieved as it remained in the guiding catheter.Another xience xpedition was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Upon further review the xience xpedition met resistance with anatomy during advancement and during removal with the guiding catheter.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for evaluation.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 circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: device code 2920 removed and 2524 added.D9 - device available for evaluation updated from yes to no.
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Search Alerts/Recalls
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