Model Number S-45-040-120-P6 |
Device Problems
Difficult to Remove (1528); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned 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 that during deployment the stent inadvertently interacted with the introducer sheath; thus resulting in the reported difficult to remove and the reported stent migration.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 performed to treat a lesion in the popliteal artery with mild calcification and mild tortuosity.One first supera stent was successfully implanted.Another 4.50x40mm supera self expanding stent system (sess) was advanced and the stent was deployed.During removal of the sess, the supera stent migrated.A portion of the stent remained in the target lesion, while a portion of the stent was in healthy tissue.Another non-abbott stent was implanted to treat the rest of the target lesion.There was no adverse patient effect and no clinically significant delay in the procedure.
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Search Alerts/Recalls
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