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Model Number H7493911338300 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years and older.Device is a combination product.(b)(4).
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Event Description
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It was reported that a stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 38mm in length target lesion was located in the severely tortuous, severely calcified and 3mm in diameter right coronary artery.A 3.00x38mm promus element¿ long stent was advanced to treat the target lesion.However, the device could not cross the lesion and it was noted that the stent struts were deformed.The device was removed and the procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: stent delivery system was returned for analysis.A visual and microscopic examination of the stent found damage to proximal stent rows 3,6 and 11 with stent struts lifted and pulled distally.The crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The distal tip was visually and microscopically examined and no damage was noted.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 tactile examination of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that a stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 38mm in length target lesion was located in the severely tortuous, severely calcified and 3mm in diameter right coronary artery.A 3.00x38mm promus element¿ long stent was advanced to treat the target lesion.However, the device could not cross the lesion and it was noted that the stent struts were deformed.The device was removed and the procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.
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Search Alerts/Recalls
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