Model Number 1804300-08 |
Device Problems
Difficult to Remove (1528); Material Too Rigid or Stiff (1544); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2022 |
Event Type
malfunction
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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 circumflex artery that is 99% stenosed.During advancement of the 3.8x08mm xience skypoint stent delivery system (sds) met resistance with anatomy as well as during removal of the sds.In the physician's opinion the no cross was also due to the stent not being as flexible.The procedure was completed with a non-abbott stent.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
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Manufacturer Narrative
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The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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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.
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Search Alerts/Recalls
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