Model Number H7493926232400 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/10/2018 |
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 was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
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Event Description
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It was reported that the stent damage occurred.The target lesion was located in a coronary vessel.A 4.00 x 32mm synergy drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and it was noted that the stent struts were lifted.The procedure was completed with another of same device.No patient complications were reported and the patient's status was good.
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Search Alerts/Recalls
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