Model Number PED-450-35 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 01/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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The pipeline flex device will not be returned for evaluation as it remains implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2017-00067.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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Event Description
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Medtronic received report that a patient required retreatment approximately fifteen months after pipeline flex implantation.It was reported that two pipeline flex devices were implanted in the treatment of a left cavernous internal carotid artery (ica).There were no device issues reported during implantation.Fifteen months post-implantation, it was reported the aneurysm still remained so an additional pipeline flex was implanted.
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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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