Model Number 10673 |
Device Problems
Break (1069); Difficult to Advance (2920)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Age at time of event: 18 years or older.
|
|
Event Description
|
It was reported that shaft break occurred.Vascular access was obtained via femoral artery.The target lesion with significant bend of >45 and <90 degrees was located in the mildly calcified right coronary artery.A 20 x 2.75 promus elite drug-eluting stent was selected for use.However, resistance was encountered upon advancing and it was noted that the shaft of the stent was broken.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
|
|
Manufacturer Narrative
|
A2- age at time of event: 18 years or older.Device evaluated by mfr: a promus elite ous mr 20 x 2.75mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.A 0.014 guidewire, verified with snap gauge, loaded successfully through the distal end of the tip and exited at the exchange port without issue.No other issues were identified during the product analysis.
|
|
Event Description
|
It was reported that shaft break occurred.Vascular access was obtained via femoral artery.The target lesion with significant bend of >45 and <90 degrees was located in the mildly calcified right coronary artery.A 20 x 2.75 promus elite drug-eluting stent was selected for use.However, resistance was encountered upon advancing and it was noted that the shaft of the stent was broken.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
|
|
Search Alerts/Recalls
|