Catalog Number 11011-29 |
Device Problems
Device Dislodged or Dislocated (2923); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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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 prior to the procedure during insertion of the 8.0mmx29mmx135cm omnilink elite stent delivering system (sds) into the introducer sheath, the stent dislodged but remained on the balloon and was noted to have flared struts.The sds was prepped after the sheath/stylet removal with no force or manipulation noted during removal.Another abbott device was used to complete the procedure.There were no adverse patient effects and 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 and material deformation were confirmed.The reported difficulty to advance could not be confirmed due to the condition the device was received 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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the introducer sheath during advancement causing the reported difficulty to advance and subsequent stent dislodgement with material deformation (misaligned, bent, stretched and overlapping stent struts).There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initially filed mdr report, it was reported that resistance was felt during advancement into the introducer sheath.The stent delivery system was removed from the introducer sheath and the stent dislodged outside the anatomy.Additionally, the stent was noted to have flared struts.No additional information was provided.
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Search Alerts/Recalls
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