Catalog Number 1076350-12 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2016 |
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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported after the 3.5 x 12 mm xience prox stent was implanted, the shaft broke in two pieces when the device was withdrawn without resistance.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.Evaluation summary: the device was returned for analysis.The reported shaft detachment was able to be confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the device was being withdrawn inadvertent mishandling resulted in the reported shaft detachment.A review of the lot history record identified no manufacturing nonconformities issued to the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 other incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the previously filed medwatch report, additional information has been received as follows: the stent implant was not deployed as previously reported.No additional information was provided.
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Search Alerts/Recalls
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