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 during preparation of a procedure to treat a lesion in the hepatic artery with 80% stenosis.The 8.0/60mm absolute pro self expanding stent system (sess) was being cleaned, when it was noted not loosened and exposed.Another absolute pro self stent was used to complete the procedure.There was no problem noted with the deployment mechanism.There was no device use or patient involvement, 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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Event Description
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Subsequent to the initially filed report, the the device was received.The stent was noted to be partially exposed but not flowered with blood noted inside the sheath and inner member was because the device was inserted in the patient's anatomy.No additional information was provided.
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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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during preparation/cleaning for use and/or during advancement onto the guide wire resulted in the reported/noted premature activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: the patient code 2645 has been updated to 2199.
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Search Alerts/Recalls
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