Catalog Number 1076400-12 |
Device Problems
Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2019 |
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.(b)(4).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 prox device is currently not commercially available in the us; 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 the procedure was to treat a moderately tortuous and moderately calcified mid ramus intermedius artery.An unspecified guide wire was advanced to the lesion, and pre-dilatation was performed with an unspecified balloon catheter.A 4.0 x 12 mm xience prox stent delivery system (sds) was then used.The balloon was inflated; however, there was difficulty in deploying the stent at first.The balloon was then inflated five times at 23 atmospheres and the stent was implanted; it was well apposed to the vessel.However, the stent delivery balloon could not be removed from the stent during removal.Therefore, the balloon was inflated again and then fully deflated.The sds was then able to be removed from the stent.There were no 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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Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported difficulty to deploy could not be confirmed as the stent was not returned for analysis.The reported difficulty to remove the device was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use, states: note: do not exceed the labeled rated burst pressure (rbp).In this case, it does not appear the ifu deviation contributed to the reported difficulties.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 was unable to determine a conclusive cause for the reported difficulty to deploy.The reported difficulty to remove appears 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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