Model Number H7493911328250 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(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 a coronary artery.A 2.50x28mm promus element¿ drug-eluting stent was advanced but failed to cross the lesion.The stent was noted to be lifted up.The procedure was completed with another of the same device.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: promus element,mr,ous 2.50x28mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Proximal stent rows 1 and 2 were damaged with stent struts lifted and pulled in a distal direction.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 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 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 a coronary artery.A 2.50x28mm promus element drug-eluting stent was advanced but failed to cross the lesion.The stent was noted to be lifted up.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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