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Model Number H7493911338350 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).Device evaluated by mfr: promus element,mr,ous 3.50x38mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Proximal stent rows were damaged and lifted from the stent profile.The undamaged crimped stent od(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 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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Reportable based on device analysis completed on 12-oct-2018.It was reported that crossing difficulties were encountered.Vascular access was obtained via the right femoral artery.The non-totally occluded, concentric, de novo target lesion was located in the non-calcified left anterior descending artery.After 6f guide catheter was engaged and a 0.014" guide wire was advanced, pre-dilatation was performed with a 3.00mm balloon catheter at 12 atmospheres.A 3.50x38mm promus element ¿ long drug-eluting stent was then advanced but failed to cross the lesion due to the angulation.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal stent damage.
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Search Alerts/Recalls
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