Model Number H7493926228220 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product (b)(4).
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Event Description
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Same case as mfr report#: 2134265-2017-12464 it was reported that stent damage occurred.During the procedure, a 2.25x28mm synergy drug-eluting stent was advanced to treat the very tortuous and moderately calcified lesion.A small resistance was felt while positioning the stent.After the stent was withdrawn in order to dilate the lesion again, open struts of the stent were noted.Thus another 2.25x28mm synergy drug-eluting stent was advanced to treat the lesion, but there was resistance advancing the device and the stent became damaged.The procedure was completed with another 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: synergy ous mr 2.25 x 28mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified distal stent damage.The distal end of the stent was damaged with stent struts lifted and pulled in a distal direction.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 multiple hypotube kinks.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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Same case as mfr report#: 2134265-2017-12464.It was reported that stent damage occurred.During the procedure, a 2.25x28mm synergy drug-eluting stent was advanced to treat the very tortuous and moderately calcified lesion.A small resistance was felt while positioning the stent.After the stent was withdrawn in order to dilate the lesion again, open struts of the stent were noted.Thus another 2.25x28mm synergy drug-eluting stent was advanced to treat the lesion, but there was resistance advancing the device and the stent became damaged.The procedure was completed with another 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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