Catalog Number 1011709-38 |
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 03/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a lesion located in the left anterior descending coronary artery that was both moderately calcified and tortuous.The xience prime failed to cross and the distal shaft separated in two parts, but was simply withdrawn with no intervention required.There was slight resistance during removal.There were no reported adverse patient effects and no clinically significant delay in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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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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A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported failure to advance and difficult to remove could not be evaluated as the exact anatomical conditions encountered by the device during the procedure could not be replicated in the test laboratory.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 the operational context 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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