Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Therapeutic Response, Decreased (2271)
|
Event Date 11/14/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
The pipeline device will not be returned for evaluation.From the reported information, there did not appear to be any issues with the pipeline device during implantation.The patient required retreatment due to distal endoeak; the cause of the distal endoleak could not be conclusively determined from the reported information.Mdrs related to this patient: 2029214-2016-01107 2029214-2016-01108.
|
|
Event Description
|
Medtronic received report that a patient underwent retreatment after pipeline implantation.The pipeline had been implanted to treat an unruptured, saccular aneurysm in the right cavernous internal carotid artery (ica).It was reported that distal endoleak was visible, so the patient underwent retreatment.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|