Catalog Number 1011708-33 |
Device Problems
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 04/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a de novo, heavily calcified and heavily tortuous vessel in the ostio-proximal left anterior descending (lad) artery.Adequate pre-dilatation was performed.The 2.75x33mm xience prime stent delivery system (sds) failed to cross due to the anatomy after multiple attempts.The proximal part of the hypotube of the stent broke into 2 parts but there was no injury to the vessel and was simply withdrawn.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.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 not returned for analysis.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 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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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 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.D9/h3: subsequent to filing the initial report(s) the complaint device was received.Return status has been updated.H6: type of investigation code 4114 removed.
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Search Alerts/Recalls
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