Catalog Number 1012632-29 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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Event Date 10/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 indication of a lot specific product quality issue.Based on the information provided, the reported difficulties and subsequent treatments appear to be due to case circumstances.It is likely that after the failed attempt to advance, the stent became loosened on the balloon due to interaction with the anatomy, resulting in the dislodgment during removal.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 target lesion in the heavily tortuous and moderately calcified right common iliac artery.The omnilink stent delivery system was advanced; however, due to the patient anatomy, the device was unable to cross to the target lesion.The stent delivery system was removed without resistance, but the stent dislodged, remaining on the guide wire, but outside the sheath.An attempt was made to advance an unspecified dilatation catheter to the dislodged stent, to expand the stent to the vessel wall, but the dilatation catheter could not be advanced through the stent.The decision was made to push the sheath and stent into the external iliac artery and a second stent was implanted, crushing the dislodged stent to the vessel wall.An additional same size omnilink stent was implanted to treat the target lesion.A procedure delay was reported, due to the amount of time to treat the dislodged stent; however, no adverse patient effects occurred due to the delay.No additional information was provided.
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Search Alerts/Recalls
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