Model Number PED2-500-20 |
Device Problems
Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Positioning Problem (3009); Activation Failure (3270)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 07/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device involved in the event will not be returned for evaluation as it was implanted in the patient; therefore, the event cause could not be determined.For 2nd pipeline, please refer to mdr# 2029214-2018-00681.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that the distal segment of the medtronic flow diverter would not open as it was deployed and had to be opened by balloon angioplasty.There was no friction or difficulty delivering this flow diverter to the intended location.The middle segment was positioned on a bend.There was stenosis observed so it was decided to balloon angioplasty the section and deploy the second medtronic flow diverter through this section.Upon deploying the second flow diverter more than 50%, the distal and middle section of the flow diverter would not open and started to flatten out.The flow diverter was resheathed and deployed again two times with the same problem occurring.It was noted that the proximal and distal segment of the flow diverter was positioned on a bend.The second flow diverter was then resheathed and removed from the patient.A third medtronic flow diverter was then deployed without any issues.A carotid stent was also deployed through the stenosis.Post procedural angiography showed a good result with stasis in aneurysm and all stents.The multiple stents were needed due to the stenosis.The patient¿s anatomy was noted to be severely tortuous.No patient injury was reported as a result of the event.The patient was undergoing embolization of an unruptured amorphous aneurysm measuring 8mm x 6mm located in the cavernous segment of the left internal carotid artery (ica).The distal and proximal landing zone was 4.3mm by 5mm.The patient was administered dual antiplatelet treatment (dapt), but the pru level was not known.A continuous flush was maintained during the procedure.The pushwire of the first medtronic flow diverter will not be returned.The second medtronic flow diverter is in the process of being returned.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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