Catalog Number UNK XIENCE SKYPOINT |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/23/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The unique device identifier (udi) is unknown because the part number and lot number were not provided.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 approximately 2 weeks post xience skypoint stent implantation in the left anterior descending (lad) artery, the patient presented in the emergency room and the stent was noted as compromised.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.The electronic lot history record (lhr) review and similar incident query for this product was not performed because the part and lot number was not reported.A failure mode was not reported for the device and no information was available; therefore, a root cause cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|