Catalog Number SBI060040080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Stenosis (2263)
|
Event Date 12/01/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
During the index procedure one mdt standard pta was used to treat the venous outflow of the left limb.Approx.14 months post index procedure, avf shunt stenosis was reported.The patient was treated with medication and revascularization of venous outflow was carried out using a non-mdt pta.The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel medication.The patient recovered.
|
|
Manufacturer Narrative
|
Cec assessed the event as related to the index device and not related to the index procedure or paclitaxel.Cec commented that the pci of the target limb was clinically driven and involved the target lesion.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
The patient has a medical history of hypertension, hyperlipidemia, diabetes, renal insufficiency and previous peripheral revascularisation of the anastomosis.The lot number was received.During a revascularisation procedure one mdt balloon was used to treat the venous outflow.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|