Model Number H7493926232270 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/21/2018 |
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 85% stenosed target lesion was located in the severely calcified mid to distal left circumflex artery.A 2.75 x 32mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion due to calcification.It was noted that the stent structure was damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Event Description
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It was reported that stent damage occurred.The 85% stenosed target lesion was located in the severely calcified mid to distal left circumflex artery.A 2.75 x 32mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion due to calcification.It was noted that the stent structure was damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated. device evaluated by mfr.: synergy ous mr 2.75 x 32mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified proximal stent damage.Damage was noted to the 3 most proximal stent strut rows.The undamaged crimped stent outer diameter was measured and was within maximum 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 a hypotube kink 480 mm distal to the distal end of the strain relief.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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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that stent damage occurred.The 85% stenosed target lesion was located in the severely calcified mid to distal left circumflex artery.A 2.75 x 32mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion due to calcification.It was noted that the stent structure was damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ous mr 2.75 x 32mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified proximal stent damage.Damage was noted to the 3 most proximal stent strut rows.The undamaged crimped stent outer diameter was measured and was within maximum 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 a hypotube kink 480 mm distal to the distal end of the strain relief.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 85% stenosed target lesion was located in the severely calcified mid to distal left circumflex artery.A 2.75 x 32mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion due to calcification.It was noted that the stent structure was damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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