Model Number H7493926038250 |
Device Problems
Bent (1059); Device Damaged by Another Device (2915)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).
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Event Description
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It was reported that stent damage occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 2.50 x 38 synergy ii drug-eluting stent was advanced to treat the lesion.However, while trying to enter a 5.5fr non-bsc guide extension catheter, the stent got interfered within the guide catheter and a stent strut was lifted.The procedure was completed with another 2.50 x 38 synergy ii drug-eluting stent.No patient complications were reported and the patient was doing great.
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Manufacturer Narrative
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Device evaluated by mfr: a synergy ii us mr 2.50 x 38mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified distal stent damage.Distal stent rows 1-3 were damaged with stent struts lifted and pulled proximally.The undamaged crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.The balloon cones were reviewed and no damage was noted to the balloon.The wings of the distal balloon cone were tightly wrapped and evenly folded.The proximal balloon cone folds were bunched in appearance.It did not appear that the balloon had been to positive pressure.A visual and tactile examination found a hypotube kink 470 mm distal from the distal end of the strain relief.A visual and tactile examination of the shaft polymer extrusion revealed no issues.The device was loaded on a 0.014'' guide wire without issue or resistance.A visual and microscopic examination of the tip identified no tip damage.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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It was reported that stent damage occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 2.50 x 38 synergy ii drug-eluting stent was advanced to treat the lesion.However, while trying to enter a 5.5fr non-bsc guide extension catheter, the stent got interfered within the guide catheter and a stent strut was lifted.The procedure was completed with another 2.50 x 38 synergy ii drug-eluting stent.No patient complications were reported and the patient was doing great.
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Search Alerts/Recalls
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