Model Number 10618 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the non-calcified and non-tortuous right coronary artery.A 4.00 x 16 synergy drug eluting stent was introduced to treat the target lesion.Significant resistance was encountered while advancing.The stent was implanted and during post dilation the stent fractured.Another stent was implanted to complete the procedure.The patient status was stable.
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Event Description
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It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the non-calcified and non-tortuous right coronary artery.A 4.00 x 16 synergy drug eluting stent was introduced to treat the target lesion.Significant resistance was encountered while advancing.The stent was implanted and during post dilation the stent fractured.Another stent was implanted to complete the procedure.The patient status was stable.It was further reported that the lesion was prepared with a 3.5mm diameter semi-compliant balloon.The stent was noted to be fractured on the proximal region.Post dilatation was performed with a 4.0 mm x 8mm nc balloon catheter at up to 18 atmospheres.
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Manufacturer Narrative
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A2: age at time of event: 18 years or older.
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Search Alerts/Recalls
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