Catalog Number 1120275-33 |
Device Problems
Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional xience alpine referenced is filed under a separate medwatch report number.
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Event Description
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It was reported that the procedure was to treat a heavily calcified, heavily tortuous left anterior descending artery.Two xience alpine stent delivery systems (2.5x23mm and 2.75x33mm) failed to cross and both shafts on each device were noted to be "fractional" (break) and kinked.Another unspecified stent was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
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Manufacturer Narrative
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The device was inadvertently discarded or misplaced and can no longer be located for analysis or testing.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9: device available for eval updated from "yes" to "no".H3: reason device not evaluated by mfg was updated to na.
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Search Alerts/Recalls
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