Catalog Number 1011343-40 |
Device Problems
Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/13/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.
|
|
Event Description
|
It was reported that the procedure was to be performed to treat a lesion in the right internal carotid artery with moderate tortuosity and heavy calcification.A 6.0x40 mm acculink self-expanding stent system (sess) was advancing, but resistance met with the tortuosity causing the delivery catheter sheath to become kinked.The sess could not cross the target lesion and then the sheath became bent.Therefore, the sess was removed from the patient; however, after the sess was removed, the sheath became separated from the device.The procedure was aborted and rescheduled to be performed at a later date.The patient is stable.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
Visual analysis was performed on the returned device.The reported separation and damage to the shaft was confirmed.The failure to advance was not able to be confirmed as it was based on procedural circumstances.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 complaints.The investigation determined that the reported difficulties were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Search Alerts/Recalls
|