Catalog Number 1012631-59 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Event Description
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It was reported that the procedure was to treat the iliac artery with moderate calcification, moderate tortuosity and 99% stenosis.Access was via the radial artery.Pre-dilatation was performed; however, it was not enough.There was difficulty with the anatomy during advancement of the 8x59 mm omnilink elite stent delivery system (sds) and during removal there was resistance with the anatomy and the stent came off of the balloon.The stent was ultimately deployed where it dislodged in the brachial artery.The target lesion was treated with additional balloon dilatation and another omnilink elite stent.There was a delay in the procedure but no reported harm to the patient.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.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 incidents.The reported difficulties and subsequent unexpected medical intervention and foreign body in patient appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - impact code 4641 removed; 4614 added.
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Event Description
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It was reported that the procedure was to treat the iliac artery with moderate calcification, moderate tortuosity and 99% stenosis.Access was via the radial artery.Pre-dilatation was performed; however it was not enough.There was difficulty with the anatomy during advancement of the 8x59 mm omnilink elite stent delivery system (sds) and during removal there was resistance with the anatomy and the stent came off of the balloon.The stent was ultimately deployed where it dislodged in the brachial artery.The target lesion was treated with additional balloon dilatation and another omnilink elite stent.There was a delay in the procedure but no reported harm to the patient.Subsequent to the initially filed report, it was reported that the sds balloon was used to deploy the stent in the arm with a low inflation.No additional information was provided.
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Search Alerts/Recalls
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