Catalog Number 1070300-15 |
Device Problems
Detachment Of Device Component (1104); 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 11/12/2017 |
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 moderately tortuous and moderately calcified de novo mid left anterior descending artery.A 3.0 x 15 mm xience xpedition stent delivery system (sds) was advanced towards the lesion; however, the device met resistance with an unspecified guiding catheter even after an attempt was made to push the device forward.When the sds was being removed, it became stuck with the guiding catheter, and the mid-proximal shaft of the sds separated inside the guiding catheter which was inside the anatomy.Therefore, the device was simply removed and another unspecified guiding catheter was inserted and an unspecified 3.0 x 18 mm xience stent was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.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 shaft detachment was able to be confirmed.The reported difficult to position and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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.It should be noted the xience xpedition everolimus eluting coronary stent system instructions for use states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.Maintain guide wire placement across the lesion and remove the delivery system and guiding catheter as a single unit.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error.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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