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Model Number 364488 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Combination product: yes.
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Event Description
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An orsiro drug-eluting stent system was selected for treatment of a severely calcified lesion (70 percent stenosis degree) in the moderately tortuous part of the mid lad.After failing to cross the lesion despite pre-dilatation, the stent dislodged from balloon in the distal third of the left coronary trunk.Several attempts were made to remove the stent, but these were unsuccessful, and the stent had to be implanted in situ.
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Manufacturer Narrative
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Combination product: yes.Neither the affected device 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 fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100% and the stent retention force of a defined amount of samples is tested by means of manufacturing process output monitoring.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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