Model Number 9548 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that stent damage occurred.The 75% stenosed target lesion was located in the calcified and mildly tortuous proximal left circumflex (lcx) artery.A 12 x 3.00 promus premier stent was advanced to the lesion and resistance occurred.The stent was removed and stent damage was noticed.It was noted that the resistance and stent damage were likely due to too much calcium.The procedure was completed with another of the same device and everything went well.There were no patient complications and the patient was fine.
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Manufacturer Narrative
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A 12 x 3.00mm promus premier stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the distal end of the stent were lifted and pulled distally.The undamaged stent od (outer diameter) was measured 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 signs of distal tip 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 inch guidewire 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.
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Event Description
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It was reported that difficulty advancing a stent and stent damage occurred.The 75% stenosed target lesion was located in the calcified and mildly tortuous proximal left circumflex (lcx) artery.A 12 x 3.00 promus premier stent was advanced to the lesion and resistance occurred.The stent was removed and stent damage was noticed.It was noted that the resistance and stent damage were likely due to too much calcium.The procedure was completed with another of the same device and everything went well.There were no patient complications and the patient was fine.
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Search Alerts/Recalls
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