Model Number FDS32512 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Ischemia Stroke (4418)
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Event Date 05/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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The subject device is unavailable to manufacturer.
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Event Description
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On may 18th, during the procedure, the flow diverter (subject device) was successfully implanted into the right p1 segment.It was reported that a day later, the patient had stroke symptoms.Upon doing a diagnostic, it was noticed that the flow diverter (subject device) had drifted one to two centimeter away from where it was implanted.On the 19th, a second surgery was done to correct it and successfully completed.No other information was provided.
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Event Description
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On (b)(6), during the procedure, the flow diverter (subject device) was successfully implanted into the right p1 segment.It was reported that a day later, the patient had stroke symptoms.Upon doing a diagnostic, it was noticed that the flow diverter (subject device) had drifted one to two centimeter away from where it was implanted.On the 19th, a second surgery was done to correct it and successfully completed.No other information was provided.
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Manufacturer Narrative
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Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that the patient had stroke symptoms 24 hours post procedure and it was noticed that the stent had drifted 1-2cm away from where it was implanted.A second procedure was done to correct it.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
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Search Alerts/Recalls
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