Catalog Number RSINT30022X |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
During the procedure, an attempt was made to use one resolute integrity drug eluting stent to treat a moderately tortuous and severely calcified lesion.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the stent deformed during positioning due to use of the device in difficult lesion morphology.Procedure was completed using a non-medtronic device.Patient status post-procedure is alive with no injury.
|
|
Manufacturer Narrative
|
Device evaluation: there was a kink on the catheter 34.4cm distal to the strain relief.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to the distal stent wraps.No deformation was evident to the distal tip.The 0.015 inch mandrel would not load through the guidewire lumen due to hardened blood in the guidewire lumen.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
|