Catalog Number 1550225-18 |
Device Problems
Difficult To Position (1467); 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 05/29/2018 |
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.(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 relevant information.
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Event Description
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It was reported that the procedure was to treat a lesion in the 1st diagonal coronary artery with no tortuosity, moderate calcification and 90% stenosis.A 2.25x18 mm xience sierra stent delivery system (sds) got stuck in the 6f guide catheter during advancement.Resistance removing the sds was felt and the sds had to be removed with force.The procedure was successfully completed with a 2.25x15 mm xience sierra sds.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.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 difficulty to position and remove were not confirmed.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 sierra everolimus eluting coronary stent system instructions for use (ifu) states: if unusual resistance is felt before the stent exits the guiding cathter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.The ifu deviation does not appear to have directly caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported difficulties as the reported difficulty to position and difficulty to remove from a guiding catheter was not confirmed during return device analysis.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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