Model Number 10666 |
Device Problems
Positioning Failure (1158); Failure to Advance (2524); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2021 |
Event Type
malfunction
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Event Description
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It was reported that the struts were damaged.A 28 x 4.00 promus premier select drug-eluting stent was selected for use in a percutaneous transluminal coronary angioplasty (ptca).During the procedure, the stent was advanced, but could not pass through the lesion properly.The device was positioned at the lesion site, but the stent failed to deploy.The physician removed the stent from patient and noticed the struts were damaged.The procedure completed successfully with another same device.There were no patient complications reported.
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Event Description
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It was reported that the struts were damaged.A 28 x 4.00 promus premier select drug-eluting stent was selected for use in a percutaneous transluminal coronary angioplasty (ptca).During the procedure, the stent was advanced but could not pass through the lesion properly.The device was positioned at the lesion site but the stent failed to deploy.The physician removed the stent from patient and noticed the struts were damaged.The procedure completed successfully with another same device.There were no patient complications reported.It was further reported that the 55% stenosed target lesion was located in mildly tortuous and none calcified lesion.There were a multiple attempts made to position the stent at the lesion site.There was no any attempt made to inflate the balloon.
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Manufacturer Narrative
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Device evaluated by mfr: a promus premier select 28 x 4.00mm stent delivery system (sds) 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 stent od (outer diameter) was measured and the result was within max 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 distal tip damage.A visual and tactile examination of the hypotube shaft found no issues.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.
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Event Description
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It was reported that the struts were damaged.A 28 x 4.00 promus premier select drug-eluting stent was selected for use in a percutaneous transluminal coronary angioplasty (ptca).During the procedure the stent was advanced but could not pass through the lesion properly.The device was positioned at the lesion site, but the stent failed to deploy.The physician removed the stent from patient and noticed the struts were damaged.The procedure completed successfully with another same device.There were no patient complications reported.It was further reported that the 55% stenosed target lesion was located in mildly tortuous and none calcified lesion.There were a multiple attempts made to position the stent at the lesion site.There was no any attempt made to inflate the balloon.
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Search Alerts/Recalls
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