Model Number PED-500-16 |
Device Problems
Physical Resistance (2578); Activation Failure (3270)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Brand name = pipeline flex with shield the device has been returned and evaluation is anticipated.A supplemental report will be submitted upon completion of investigation.
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Event Description
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Medtronic received information that during treatment of an aneurysm located in the left parophthalmic, the device was not opening distally.It was reported that the device was pushed to the distal end of microcatheter and the whole system was pulled backwards to cover the aneurysm neck and to take the slack away.The microcatheter was thereafter pulled to open the distal end of the device.The microcatheter was pulled approximately half of the length of the device and "no opening" of the device was seen.The device was resheathed and redeployed three times with no success.Thereafter the device was pulled back into the microcatheter and removed from the patient.The aneurysm was treated with coiling and a competitors stent.
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Manufacturer Narrative
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Device available for evaluation - additional information type of follow up - device evaluation.Device evaluated by manufacturer.Additional information: the device was returned within a competitors microcatheter.For further examination, the device was removed from the catheter hub.The device was found fully opened with damaged braid at both ends.The customer¿s clinical observation could not be confirmed.Based on the analysis we are unable to conclusively determine the cause of this event.The damage to the braid on both ends of the pipeline is likely the result of the physician resheathing the device more than the recommended two times.Per our instructions for use, the user should "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.The system is designed to allow for 2 full cycles of resheathing of the pipeline flex embolization device.Resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.¿ suspect medical device = pipeline flex with shield technology model # = ped2-500-16.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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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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