Model Number H7493926220350 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is combination product.(b)(4).
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Event Description
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It was reported that stent damage occurred.Coronary angiography was performed which revealed an 87% stenosed target lesion located in the moderately tortuous and severely calcified mid left anterior descending artery.After a non-bsc guide wire crossed the lesion, pre-dilatation was performed using a 3.0 x 15 non-bsc balloon catheter.A 3.50 x 20 synergy¿ drug-eluting stent was then advanced but failed to cross the lesion due to the calcification and the distal stent strut was damaged.The device was removed and the procedure was completed with another 3.50 x 20 synergy¿ drug-eluting stent, followed by post-dilatation using an nc emerge balloon catheter.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 3.50 x 20mm stent delivery system was returned for analysis.An examination of the crimped stent revealed stent damage.Distal struts 1-8 were undamaged; the remainder of the struts were damaged and bunched in a distal direction.The undamaged crimped stent outer diameter was measured and the result was within the specification.The balloon cones were reviewed and there were no issues to note.The balloon wings were tightly wrapped and evenly folded.A visual and tactile examination of the hypotube revealed no issues.An examination of the shaft polymer extrusion found no issues.There were no signs of damage or strain to the port bond.The tip was visually examined and no issues were noted.No other issues were identified during the product analysis.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.Coronary angiography was performed which revealed an 87% stenosed target lesion located in the moderately tortuous and severely calcified mid left anterior descending artery.After a non-bsc guide wire crossed the lesion, pre-dilatation was performed using a 3.0 x 15 non-bsc balloon catheter.A 3.50 x 20 synergy¿ drug-eluting stent was then advanced but failed to cross the lesion due to the calcification and the distal stent strut was damaged.The device was removed and the procedure was completed with another 3.50 x 20 synergy¿ drug-eluting stent, followed by post-dilatation using an nc emerge balloon catheter.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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