Model Number H7493952816400 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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 the stent damage occurred.The target lesion was located in a coronary vessel.A 4.00x16mm promus premier¿ drug-eluting stent was advanced to treat the target lesion.However, the device was unable to cross and the stent raised off the balloon.No patient complications were reported.
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Search Alerts/Recalls
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