|
Catalog Number AB35W10040135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Stenosis (2263)
|
Event Date 01/03/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
During the index procedure, a medtronic standard pta was used to treat the right cephalic arch and a medtronic balloon was also used for post dilation.Approximately 14.5 months post index procedure patient suffered cephalic vein stenosis in avf.The same day, event was treated with non medtronic pta of venous outflow and medication.Investigator and sponsor assessed the event as not related to the index device or antiplatelet medication.Patient recovered.Cec adjudicated revascularization is not clinically driven, this is a target lesion revasc.Cec also adjudicated event is related to device but not related to procedure or therapy.
|
|
Manufacturer Narrative
|
Additional information: patient is a former smoker with a medical history of hypertension, hyperlipidemia, diabetes, renal insufficiency, coronary heart disease, congestive heart failure, peripheral artery disease and previous pta of the cephalic arch.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
It was reported that an admiral 7x80 balloon was used during the index procedure.No lot details recorded.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
It was reported that an evercross pta balloon (10x40mm) was used to post dilate lesion during index procedure.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|