Model Number 1125400-15 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).
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Event Description
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It was reported that the procedure was performed to treat a lesion in the left main coronary artery.A 4x15mm xience alpine stent delivery system (sds) was advanced, and the stent was deployed.The sds was removed from the anatomy, but then the sds was reinserted and used for dilatation.The balloon of the sds only partially deflated and was removed along with an unspecified guide wire.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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Device code 2017 - reinsertion.It should be noted that the instructions for use (ifu) xience alpine everolimus eluting coronary stent system states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2017: re-insertion was added.
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Manufacturer Narrative
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The device was returned for analysis.The reported deflation issue was unable to be confirmed.The reported difficulty to remove was unable to be confirmed 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 identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2017/reinsertion removed.
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Search Alerts/Recalls
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