Model Number RONYX20030UX |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/04/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
A resolute onyx drug eluting stent was intended to be used to treat a lesion patient's proximal ramus which had no tortuosity, no calcification and 70% lesion stenosis.No abnormalities were reported in relation to the anatomy.No damage was noted to packaging.No issues were noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was not used.It was reported that the stent did not cross the lesion.Upon removal from the patient, it was noted that the stent had a lifted strut.Another medtronic stent was used to complete the procedure.The patient is alive with no injury.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Product analysis summary: there was a kink on the catheter 39cm distal to the strain relief.There was a kink on the distal shaft 37.2cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 14th and 23rd distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|