Catalog Number 1125225-23 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the procedure was to treat a lesion located in the distal right coronary artery.The xience alpine 2.25 x 23 mm stent delivery system (sds) was advanced to the lesion but failed to cross due to the patient anatomy.The sds was removed from the anatomy and the proximal struts of the stent were found to be flared.There was resistance reported during withdrawal of the device from the anatomy.A new xience alpine was used to complete the procedure.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.The reported material deformation was able to be confirmed.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system was advanced resistance was met with the anatomy resulting in the reported failure to advance.Interaction with the anatomy and/or other devices as the device was being removed resulted in the reported/noted material deformation (stretched, bent) thus resulting in the reported difficulty to remove.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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