Catalog Number 1011528-18 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Internal file number - (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 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 the arterial trunk of a calcified renal artery.A 5.0 x 18 mm herculink elite was being advanced when there was resistance with the anatomy while attempting to cross the lesion and the stent dislodged.A balloon catheter was used to remove the dislodged stent.Pre-dilatation was performed with an unspecified balloon and an unspecified stent was successfully deployed to complete the procedure.There was a reported 30 minute delay in procedure, but no adverse patient sequela.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account.The device was not returned for analysis.It is likely that during the failed attempt to advance, the stent dislodged within the lesion.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties are related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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