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Model Number 419110 |
Device Problems
Failure to Advance (2524); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2024 |
Event Type
malfunction
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Event Description
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An orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion (90 percent stenosis degree) in a moderately tortuous mid lcx.It was tried to deliver the orsiro mission, but it seemed to be getting stuck.After removal it was detected that stent struts were curled up (deformed), so it was replaced with another orsiro mission.The procedure was completed without any problems.
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Manufacturer Narrative
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Combination product: yes.
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Manufacturer Narrative
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Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the stent is severely deformed at its proximal end, i.E.Several struts are strongly bent.The balloon is well folded and shows no signs of inflation.Stent imprints on the exposed balloon surface indicate that the bent struts were initially crimped on the balloon.Outside of the deformed zone, the crimped diameter of the stent complies with the specification.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.
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Search Alerts/Recalls
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