Catalog Number UNK-CV-GWY-ADM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Patient Problem/Medical Problem (2688)
|
Event Date 05/29/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
During the index procedure the left anastomosis was pre-dilated with a medtronic balloon and treated with a medtronic standard pta medtronic balloon catheter.Approximately 9 months post index procedure, patient suffered a high grade stenosis of the avf in the juxta anastomotic region.The patient was treated with medication and a non medtronic pta in the anastomosis.The investigator assessed this event as not related to the index device, procedure or paclitaxel.The event is resolved.
|
|
Manufacturer Narrative
|
During the index procedure a reef balloon catheter was used to treat the anastomosis.Safety assessed the event as not related to the index device, procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
The anastomosis was further treated with a non-mdt pta.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Cec adjudicated event as not related to procedure or therapy but related to device.Revascularization is clinically driven.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|