Model Number 10604 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The 100% stenosed target lesion was located in the left anterior descending artery.A 2.25 x 24mm synergy ii drug eluting stent was advanced for treatment.However, during insertion, the shaft was fractured.The device was removed with the wire and the procedure was completed with a new stent.There were no patient complications reported.
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Event Description
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It was reported that shaft break occurred.The 100% stenosed target lesion was located in the left anterior descending artery.A 2.25 x 24mm synergy ii drug eluting stent was advanced for treatment.However, during insertion, the shaft was fractured.The device was removed with the wire and the procedure was completed with a new stent.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ii us mr 2.25 x 24 mm stent delivery system (sds) 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 tip damage.A visual and tactile examination of the hypotube shaft found a break situated at 16.2 cm distal to the distal end of the strain relief as well as multiple hypotube 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.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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