Model Number S-55-100-120-P6 |
Device Problems
Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been received; however, analysis has not begun.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a moderately calcified left superior femoral artery (sfa).Two unspecified supera self-expanding stent were implanted without issue.The third 5.5x100mm supera stent met resistance with the 6fr sheath during advancement and removal.The supera device was removed and the shaft was noted to be kinked.The procedure was completed with a new guidewire and new supera stent.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 deformation due to compressive stress 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.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling resulted in the reported shaft kink/noted shaft and inner member kinks; thus resulting in the reported difficult to advance and the reported difficult to remove.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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