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Model Number 419134 |
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 03/15/2024 |
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 severely calcified lesion (stenosis degree: 90 percent) in the severely tortuous distal rca.After pre-dilatation (five times), an attempt was made to pass the om through the lesion, but the catheter got caught in the lesion and therefore was removed from the body.At that time, a deformation of the stent was also seen, so this device was not placed in the lesion.A dcb was performed, and the procedure completed.
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Manufacturer Narrative
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Combination product: yes.Neither the affected product nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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, no material or manufacturing related root cause could be determined.
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Search Alerts/Recalls
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