Catalog Number 1804250-18 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
|
|
Event Description
|
It was reported that the procedure was to treat a heavily calcified, heavily tortuous left anterior descending artery.The 2.5x18mm xience skypoint stent delivery system failed to cross due to anatomy.During removal resistance was felt with anatomy and the stent's struts became extended (stretched).A non-abbott device was used and the procedure was completed.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.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.
|
|
Search Alerts/Recalls
|