Catalog Number 1017350-48 |
Device Problem
Unstable (1667)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 05/17/2018 |
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.The xience pro ll is currently not commercially available in the u.S.However, it is similar to a device sold in the us.
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Event Description
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It was reported that a 3.5x48 mm xience pro stent delivery system (sds) stent struts were noted to be loose.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: a visual inspection was performed.The reported unstable stent was not confirmed.However, it is likely that the bent stent struts that were identified during the returned device analysis is the actual damage that the account identified as loose struts.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 similar incidents reported from this lot.The investigation determined the reported stent difficulties appears to be related to the operational context of the procedure.It is unlikely that the protective sheath would have fit over the stent damage identified during the device analysis; therefore, the damage is not considered a pre-existing condition.It is likely that the reported difficulties were a result of inadvertent mishandling of the device during un-packaging and/or during preparation for use.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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Event Description
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Subsequent to the initially filed report, additional reported information indicates the device was not used and there was no patient involvement.There was no reported clinically significant delay in the procedure.Percutaneous coronary intervention was performed to complete the procedure.No additional information was provided.
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Search Alerts/Recalls
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