Catalog Number 1070225-23 |
Device Problems
Detachment Of Device Component (1104); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 procedure was to treat a heavily tortuous and heavily calcified second diagonal artery that was 90% stenosed.A 2.25 x 23 mm xience xpedition stent delivery system could not cross the lesion due to the anatomy and the shaft separated.There were no adverse patient effects reported.The procedure was successfully completed by deploying a non-abbott stent.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned for analysis.The reported shaft detachment was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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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