Model Number H7493926232300 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.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 target lesion was located in the mid left anterior descending artery.A 3.00 x 32mm synergy" drug-eluting stent was advanced but failed to cross the lesion.The device was removed from the patient and it was noted that the stent struts were lifted.The procedure was completed with another 3.00 x 32mm synergy stent.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ous mr 3.00 x 32mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Damage was noted to the 4 most distal stent strut rows; stent struts were stretched distally stretched distally.The undamaged crimped stent outer diameter was measured and the result was within max 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 tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no damage to the tip.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 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 stent damage occurred.The target lesion was located in the mid left anterior descending artery.A 3.00 x 32mm synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed from the patient and it was noted that the stent struts were lifted.The procedure was completed with another 3.00 x 32mm synergy stent.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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