Model Number PED-500-35 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Brain Injury (2219)
|
Event Date 07/04/2016 |
Event Type
Death
|
Manufacturer Narrative
|
The pipeline flex device will not be returned for evaluation as it was 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: 2029214-2016-00757, 2029214-2016-00758, 2029214-2016-00759.
|
|
Event Description
|
Medtronic received report that a patient experienced infarction after pipeline flex implantation.The patient was undergoing treatment for an unruptured, fusiform aneurysm in the basilar artery.The max.Diameter was 2.5cm and neck diameter was 2cm.Vessel tortuosity was normal.All devices were prepared as indicated in the ifu.Dual antiplatelet treatment was administered; blood tests indicated that the patient is responsive to aspirin and clopidogrel.Three pipeline flex devices were implanted in a telescoping manner from 5mm below the basilar tip to the junction of the vertebral arteries.The aneurysm was then filled with non-medtronic coils.There were no issues noted during the procedure.Two hours after the procedure, the patient experienced bilateral infarction of the cerebellum.The physician reports that the infarction was not caused by the pipeline devices, but is a risk of the treatment.The patient was admitted to intensive care and later passed away.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|