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Model Number 10677 |
Device Problems
Material Rupture (1546); Failure to Advance (2524); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture and partial stent deployment occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior descending artery.Angioplasty was performed with a 2.5 x 15mm wolverine cutting balloon.A 38 x 3.00 promus elite stent was advanced for treatment.However, the device failed to cross the proximal part of the lesion.A guidezilla extension catheter was used to allow the passage of the stent.During deployment of the stent, the balloon burst on the initial inflation at 12 atmospheres and the stent was released within the artery without adequate apposition.The stent was retrieved and the entire rail system removed without complication.The procedure was completed with a 3.0 x 38mm non-boston scientific stent.No patient complications were reported, and the patient status was stable.
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Event Description
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It was reported that balloon rupture and partial stent deployment occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior descending artery.Angioplasty was performed with a 2.5 x 15mm wolverine cutting balloon.A 38 x 3.00 promus elite stent was advanced for treatment.However, the device failed to cross the proximal part of the lesion.A guidezilla extension catheter was used to allow the passage of the stent.During deployment of the stent, the balloon burst on the initial inflation at 12 atmospheres and the stent was released within the artery without adequate apposition.The stent was retrieved and the entire rail system removed without complication.The procedure was completed with a 3.0 x 38mm non-boston scientific stent.No patient complications were reported, and the patient status was stable.
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Manufacturer Narrative
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A review of the image provided by the site confirms the balloon damage/rupture.An accumulation of fluid (haziness) is visible proximally to the positioned stent and also running almost the entire length of the stent.No clear stent expansion was noted in the image provided.
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Search Alerts/Recalls
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