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Model Number 9553 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that the stent damage occurred and the patient experienced pain.The target lesion was located in a coronary artery.A 32 x 3.50 promus premier drug-eluting stent was advanced for treatment, but could not be delivered to the lesion.After withdrawing the device, the stent strut was found to be lifted and deformed resulting in increased pain, procedure time, and risk to the patient.The procedure was not completed.
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Event Description
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It was reported that the stent damage occurred and the patient experienced pain.The target lesion was located in a coronary artery.A 32 x 3.50 promus premier drug-eluting stent was advanced for treatment, but could not be delivered to the lesion.After withdrawing the device, the stent strut was found to be lifted and deformed resulting in increased pain, procedure time, and risk to the patient.The procedure was not completed.It was further reported that the 95% stenosed target lesion was located in the right coronary artery.The procedure was completed with another of same device.There were no patient complications and the patient status was stable.
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Search Alerts/Recalls
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