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Model Number 1011487-12 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for evaluation.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 complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The difficulty encountered during advancement was likely due to interaction with the anatomy.Additionally, it is likely that during the attempt to cross the lesion, the stent became compromised on the balloon resulting in dislodgement and unexpected medical intervention to retrieve the stent with a snare.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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It was reported that the procedure was performed to treat a lesion in the mildly calcified, mildly tortuous, 80% stenosed right renal artery.A 4x12mm herculink elite stent delivery system (sds) faced resistance with the anatomy during advancement, and prior to crossing the lesion, the stent dislodged completely outside the target lesion.The stent was retrieved with a snare, and a same sized herculink elite stent was used to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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