Model Number 10621 |
Device Problems
Failure to Advance (2524); Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2021 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.The 99% stenosed, eccentric, de novo target lesion was located in the severely calcified artery.The lesion contained >=90 degrees bend.Following pre-dilation, a 2.25 x 28 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and found the tip of the stent itself was deformed.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ous mr 2.25 x 28mm 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 marker bands.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.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
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Event Description
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It was reported that stent damage occurred.The 99% stenosed, eccentric, de novo target lesion was located in the severely calcified artery.The lesion contained >=90 degrees bend.Following pre-dilation, a 2.25 x 28 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and found the tip of the stent itself was deformed.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
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Search Alerts/Recalls
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