Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem
Stenosis (2263)
Event Date 09/20/2019
Event Type
Injury
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
During the index procedure one nanocross balloon and one amphirion balloon were used to treat the right anterior tibial artery.Approximately 14 months post procedure the patient suffered restenosis of right tibial artery which was treated with ballooning.The investigator assessed the event as not related to the index device or paclitaxel.The sponsor assessed the event as not related to the paclitaxel and possibly related to the index device.The patient recovered.