|
Catalog Number 1011487-15 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/27/2023 |
Event Type
Injury
|
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 on (b)(6) 2023 was to treat a 70% stenosed lesion in the left vertebral artery ostium.A guide wire was placed and pre-dilatation was performed.The 4.0x15mm herculink elite stent delivery system (sds) was attempted to be advanced to the target lesion; however, failed to advance due to the anatomy.When the sds was being removed to perform additional pre-dilatation, the stent dislodged at the ostium of the vertebral artery.The herculink sds was removed and a 1.5x15mm balloon was used to attempt to remove the stent.The stent was retracted back to the femoral artery, but was not able to be removed with the balloon.The patient had no discomfort and blood flow was smooth.The patient was placed temporarily on anti-platelet medication and monitored.Then, on 10/03/2023 digital subtraction angiography (dsa) was performed and a surgical incision was made to remove the stent.The patient is in good condition.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent surgical intervention, unexpected medical intervention (additional therapy/non-surgical treatment), and medication required 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.Na.
|
|
Search Alerts/Recalls
|
|
|