Catalog Number 11011-19 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2024 |
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 subclavian artery with mild calcification, mild tortuosity and 90% stenosis.The 8x19 mm omnilink elite stent delivery system (sds) was flushed and then advanced along the guide wire to the lesion.It was then found that the stent was loose on the balloon and far away from the distal marker.The sds balloon was inflated to keep the stent on the delivery system and then a 6fr long sheath was advanced.The sds, stent and sheath were removed together as a unit.A new same size omnilink elite sds was used to complete the procedure.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported stent dislodgement was confirmed.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.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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