Model Number 10621 |
Device Problems
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 11/11/2021 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 85% stenosed, 3mmx28mm, eccentric, de novo target lesion with a bend of >=90 degrees was located in the non-tortuous and non-calcified left circumflex artery.Following pre-dilation with a maverick balloon catheter, a 3.50 x 28 synergy ii drug-eluting stent was advanced for treatment.However, the device was unable to cross the lesion and a significant bend in the stent was noted.The procedure was completed with another of the same device.There were patient complications nor injuries reported and the patient status was stable.
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Event Description
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It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 85% stenosed, 3mmx28mm, eccentric, de novo target lesion with a bend of >=90 degrees was located in the non-tortuous and non-calcified left circumflex artery.Following pre-dilation with a maverick balloon catheter, a 3.50 x 28 synergy ii drug-eluting stent was advanced for treatment.However, the device was unable to cross the lesion and a significant bend in the stent was noted.The procedure was completed with another of the same device.There were patient complications nor injuries reported and the patient status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ous mr 3.50 x 28 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 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 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.No issues were identified during the product analysis.
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Search Alerts/Recalls
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