Model Number 10602 |
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 12/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is combination product.
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the mildly calcified left main artery into the proximal left anterior descending artery.At the course of the procedure, the physician used a 3.75 mach 1 8fr lbu guide catheter, a guidezilla ii guide extension catheter, samurai guide wire, a non-bsc guide wire, multiple balloon inflations and a choice pt guide wire.Subsequently, a 4.00 x 16mm synergy stent was advanced but failed to cross the lesion.However, it was noted that the stent had damage to the struts which was noted on the proximal stent edge.Another synergy 4.00 x 16 stent was advanced but it aslo failed to cross the lesion.The procedure was completed with a 4.0 x 8mm and a 4.0 x12mm synergy stents.No patient complications were reported.
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Manufacturer Narrative
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Device is combination product.Lot number updated from unknown to 0022618540.Expiration date updated from unknown to 08/28/2020.Unique identifier (udi) # updated from unknown to (b)(4).
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the mildly calcified left main artery into the proximal left anterior descending artery.At the course of the procedure, the physician used a 3.75 mach 1 8fr lbu guide catheter, a guidezilla ii guide extension catheter, samurai guide wire, a non-bsc guide wire, multiple balloon inflations and a choice pt guide wire.Subsequently, a 4.00 x 16mm synergy stent was advanced but failed to cross the lesion.However, it was noted that the stent had damage to the struts which was noted on the proximal stent edge.Another synergy 4.00 x 16 stent was advanced but it aslo failed to cross the lesion.The procedure was completed with a 4.0 x 8mm and a 4.0 x12mm synergy stents.No patient complications were reported.
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Search Alerts/Recalls
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