Catalog Number 1120275-28 |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/28/2019 |
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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that before use, after opening the package, there was no stent implant on the 2.75x28mm xience alpine stent delivery system (sds), and the stent was not found.The sds was not used and there was no patient involvement.The procedure was completed using an unspecified device.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported missing component (stent) was confirmed through observation.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 identified no similar incidents from this lot.The investigation determined the reported material rupture appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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Event Description
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Although it was reported that the sds was not advanced on the guide wire and had no patient contact, the device return analysis indicated the device was returned in an inserted stated which identified blood in the balloon folds and in the guide wire lumen.No additional information was provided.
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Search Alerts/Recalls
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