Catalog Number M003WE0300200 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that during stenting of a left vertebral artery (va) stenosis, the physician experienced resistance while delivering the stent (subject device) and it could not be pushed further.During manipulation of the stent, the physician fractured the hypo tube tail of the stent delivery wire section.The physician replaced it with a new stent and completed the procedure without clinical consequences to the patient.
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Manufacturer Narrative
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The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the proximal end of the stabilizer was kinked, broken.The stent was also deployed from the distal end of the delivery catheter.During functional testing, the delivery catheter was flushed and lots of procedural fluid exited the device.Information available indicated that the patients anatomy was very tortuous and it is probable anatomical or procedural factors encountered during the procedure contributed to the reported event of friction.It is probable the proximal end of the stabilizer was kinked and broken as a result of handling of the device during the clinical procedure, therefore, a cause of handling damage has been assigned to this investigation.
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Event Description
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It was reported that during stenting of a left vertebral artery (va) stenosis, the physician experienced resistance while delivering the stent (subject device) and it could not be pushed further.During manipulation of the stent, the physician fractured the hypo tube tail of the stent delivery wire section.The physician replaced it with a new stent and completed the procedure without clinical consequences to the patient.
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Search Alerts/Recalls
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