Model Number 44150 |
Device Problems
Difficult to Remove (1528); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2021 |
Event Type
Injury
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Event Description
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It was reported that the device got caught in the distal edge of the stent, fragment moved in the distal and was retrieved with a snare.The 80% stenosed target lesion was located in the internal carotid artery and common carotid artery.A 190cm filterwire ez and a wallstent were selected for use.During the procedure, a sterling and wallstent10-31 were used upon pre and post dilation.The filter became "slow flow" and it could not fit in the catheter for total retrieval.When 80% was retrieved, the device got caught in the distal edge of the wallstent.The device was removed carefully and the physician then noticed that part of the filter bag was missing.A possibility that the fragment moved to the distal side.The guiding was replaced with a cutting balloon and after aspiration, an imaging was performed and it was noted that the filter moved in the edge of the stent.The fragment was removed using a snare.A distal was not observed through ct scan.However, it will be checked again with mri the next day.No further patient complications were reported.
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Manufacturer Narrative
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(b)(6).
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Manufacturer Narrative
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E1 - initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only the filterwire distal section was received.The spring tip was observed bent, stretched and curvy and the filter was ripped.No other issues or anomalies were observed.Microscopic inspection was performed.Under microscope inspection, the filter and distal section were inspected and the spring tip was observed bent, stretched and curvy and the filter was ripped.Additionally, the wire shows evidence of a mechanical cut.Media inspection of the provided photos revealed that only the filter at distal section was visible.The filter was ripped.No other issues were observed.
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Event Description
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It was reported that the device got caught in the distal edge of the stent, fragment moved in the distal and was retrieved with a snare.The 80% stenosed target lesion was located in the internal carotid artery and common carotid artery.A 190cm filterwire ez and a wallstent were selected for use.During the procedure, a sterling and wallstent10-31 were used upon pre and post dilation.The filter became "slow flow" and it could not fit in the catheter for total retrieval.When 80% was retrieved, the device got caught in the distal edge of the wallstent.The device was removed carefully and the physician then noticed that part of the filter bag was missing.A possibility that the fragment moved to the distal side.The guiding was replaced with a cutting balloon and after aspiration, an imaging was performed and it was noted that the filter moved in the edge of the stent.The fragment was removed using a snare.A distal was not observed through ct scan.However, it will be checked again with mri the next day.No further patient complications were reported.
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Search Alerts/Recalls
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