Model Number 26606 |
Device Problem
Fracture (1260)
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Patient Problems
Stroke/CVA (1770); Foreign Body In Patient (2687)
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Event Date 02/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Implanted date: 2018.
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Event Description
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It was reported that a stent fracture and mild cerebral infarction occurred.The target lesion was located in the internal carotid and common carotid arteries.A 10.0-31 carotid wallstent monorail stent was implanted in 2018.During follow up, it was noticed that the distal part of the stent was fractured inside the patient.A mild cerebral infarction was noted, and a computerized tomography scan showed something white, as if something like a piece of metal was flying around.Additional information was requested and has not been received.No further patient complications were reported.
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Manufacturer Narrative
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E1: initial reporter facility name: (b)(6) general hospital.D6a: implanted date: 2018.Device eval.By manufacturer: the carotid device was not returned for analysis.However images of the stent were provided by the customer and were reviewed.From the images provided by the customer, it could not be positively confirmed that the stent was fractured; however it could be confirmed that the distal stent wires had been damaged.H3 other text : media.
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Event Description
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It was reported that stent fracture and mild cerebral infarction occurred.The target lesion was located in the internal carotid and common carotid arteries.A 10.0-31 carotid wallstent monorail stent was implanted in 2018.However, during follow up, it was noticed that the distal part of the stent was fractured inside the patient.A mild cerebral infarction was noted and the computerized tomography scan showed something white as if something like a piece of metal was flying around.No further patient complications were reported.
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Search Alerts/Recalls
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