Catalog Number 1012841-60 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat the subclavian artery with mild calcification, mild tortuosity and 80% stenosis.The 8x60 mm absolute pro self expanding stent system (sess) was advanced to the lesion however, it was noted that the stent was exposed.The sess was removed and a new stent was used to complete the procedure.There were no reported adverse patient effects and there was no reported 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 premature activation was able to be confirmed.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 did not indicate a lot specific quality issue.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 and/or interaction with the mildly calcified, mildly torturous and 80% stenosis anatomy resulted in the noted wrinkled sheath thus causing the stent to slightly pull out of the stent sheath and prematurely deploy (flower) resulting in the reported premature activation.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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