Model Number PED-500-18 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
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Event Description
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Medtronic received information that during treatment of an aneurysm located in the right carotid syphon, the distal segment of the pipeline did not open.The device was retrieved and another pipeline was used to complete the procedure.There was no report of patient injury.
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Event Description
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Medtronic received additional information that pipeline was positioned in a bend and the patient had moderate vessel tortuosity.It was reported that approximately 15 mm of the pipeline wad deployed with the pipeline did not open.The pipeline was resheathed 4 times and removed together with the microcatheter.There was no report of patient injury.
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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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