Model Number 1550250-12 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/19/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that this was a percutaneous coronary intervention in the heavily calcified mid left circumflex coronary artery.The 2.5x12 mm xience sierra stent delivery system (sds) was advanced without resistance when the proximal shaft separated in two pieces outside the body.The separated segment was removed from the sheath using a hemostat.The entire sds was removed without incident.Another xience sierra was inserted and used without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
|
|
Manufacturer Narrative
|
A visual inspection was performed on the returned device.The reported material separation was confirmed.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.A conclusive cause for the reported material separation could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|