Model Number 10604 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/16/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was defective.The patient came in with st-elevation myocardial infarction.The target lesion was located in a coronary vessel.A 2.25x24mm synergy drug-eluting stent was selected for use.However, upon removing the device, it was noticed that there was a bubble or a metal ring formation on the stent hypotube.The device did not enter the patient's body.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluation by mfr.: synergy ii us mr 2.25 x 24 mm 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 tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were noted with the shaft and no anomalies like a bubble was observed.The only "bubble" present is the mid-shaft bond which is part of the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that the device was defective.The patient came in with st-elevation myocardial infarction.The target lesion was located in a coronary artery.A 2.25 x 24 synergy drug-eluting stent was selected for use; however, when removing the stent from the delivery system, it was noticed that there was a bubble or a metal ring formation on the stent hypotube.The device did not enter the patient's body.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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