Catalog Number S-55-150-120-P6 |
Device Problems
Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2024 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a chronic total occlusion in the right distal superficial femoral artery with moderate calcification.During preparation of the 5.5x150 mm supera self expanding stent system (sess), the device was loaded onto a guide wire which was inside the anatomy.The guide wire wire had lots of contrast and was sticky, causing resistance during advancement and removal.When the stent was pulled off the wire, the white tip separated.Therefore, the stent was not used in the patient and another same size supera was used to complete the procedure.There were no adverse patient effects 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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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Manufacturer Narrative
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The device was returned for analysis.The reported material separation tip was able to be confirmed.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 that a coagulation of blood and contrast on the guide wire resulted in the reported difficult to advance and the reported difficult to remove.Manipulation of the compromised device resulted in the noted multiple distal sheath kinks and ultimately resulted in the reported tip separation/noted inner member/ tip jacket separations; thus resulting in the noted partially deployed/flowered stent.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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