Catalog Number 1070350-28 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that the procedure was to treat a heavily calcified, moderately tortuous left anterior descending artery.The 3.5x28mm xience xpedition stent delivery system (sds) met resistance during advancement with anatomy and the stent dislodged above the aortic value.The stent was retrieved via snare.Another xience xpedition was used to successfully complete the procedure.There were no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 identified no similar incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified and moderately tortuous artery causing the reported failure to advance and subsequent stent dislodgement.The dislodged stent was successfully removed with a snare.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|