Catalog Number 11005-39 |
Device Problems
Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
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 the procedure was to treat a mildly tortuous, mildly calcified common iliac artery that is 70% stenosed.The 9.0mmx39mm omnilink elite 35 stent was attempted to advance with the 6fr sheath; however, resistance was felt with the sheath and the stent was noted to slightly off the delivery system.The device was simply withdrawn with the stent and another omnilink elite stent with a 7f sheath was used to complete the procedure.There was no adverse patient effects and no clinically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 was 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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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It was reported that the procedure was to treat a mildly tortuous, mildly calcified common iliac artery that is 70% stenosed.The 9.0mmx39mm omnilink elite 35 stent was attempted to advance with the 6fr sheath; however, resistance was felt with the sheath and the stent was noted to slightly off the delivery system.The device was simply withdrawn with the stent and another omnilink elite stent with a 7f sheath was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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