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Model Number H7493911328300 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).F/g, promus element,mr,ous 3.00x28mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The 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 multiple hypotube kinks and a hypotube break 236mm distal from the distal edge of the strain relief.A visual and tactile examination of the 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 not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Event Description
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Reportable based on device analysis completed on 10-jan-2018.It was reported that tip damage occurred.Vascular access was obtained via the femoral artery.The non-totally occluded, de novo target lesion was located in the non-tortuous and severely calcified left anterior descending artery.After pre-dilatation was performed with a 1.5x8mm balloon catheter, a 3.00x28mm promus element¿ drug-eluting stent was advanced to treat the lesion but resistance was encountered.While negotiating over the guide wire, a kink was noted at the tip of the device.The procedure was completed with another 3.00x28mm promus element¿ drug-eluting stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a broken hypotube.
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Search Alerts/Recalls
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