Model Number 1550250-38 |
Device Problems
No Apparent Adverse Event (3189); Activation Failure (3270)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: estimated date.The additional xience sierra device referenced is filed under a separate medwatch report number.The device is expected to be returned for evaluation.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 the 3.5x38mm and 2.50x38mm xience sierra stents delivery system failed to deploy.Both devices were removed, and another unspecified stent was used to successfully complete the procedure.There was no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.General handling damage was noted during return analysis consistent with operational context; however, as no specific reported device malfunction was reported nothing was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.An investigation was not conducted because there were no specific reported device malfunctions or patient effects associated with the device.There is no indication of a product quality issue with respect to design, manufacture or labeling.H6: device code 3270 removed.
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Event Description
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Subsequent to the initially filed report, the following information was received: the devices were not deployed as it was noted that the incorrect size stents were chosen and they were undersized for the lesion.The stents were not implanted and there was no issue noted with the stents or delivery systems.No additional information was provided.
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Search Alerts/Recalls
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