ULTRA ICE PLUS - PI
Received Sep 23, 2019 · Event occurred Aug 29, 2019
Report 2134265-2019-11532 · MDR key 9105396
Device
Generic name
Catheter, Ultrasound, Intravascular
Manufacturer
Boston Scientific CorporationModel number
1816-06Catalog number
1816-06
Product problems
- Failure to Advance
- Failure to Advance
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED RESULTING IN STENT MIGRATION REQUIRING ADDITIONAL INTERVENTION. A 16 X 90 X 100 VICI SELF EXPANDING STENT WAS SELECTED FOR A LEFT COMMON ILIAC STENTING PROCEDURE. THE NON-THROMBOTIC SECTION TO BE TREATED WAS 20-30 MM. DURING THE PROCEDURE, THE STENT WAS IMPLANTED WITH NO COMPLICATIONS. THE LEADING EDGE OF THE STENT WAS PLACED IN THE PROXIMAL LCIV AND EXTENDED TO PROXIMAL LEIV. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE MULTIPLE CATHETERS INTO THE STENT AND WAS MET WITH RESISTANCE AT THE PROXIMAL OSTIUM OF THE STENT. WHEN THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE ULTRA ICE CATHETER INTO THE STENT TO VISUALIZE IT, THE VESSEL WAS SO TORTUOUS THAT THE CATHETER PUSHED AGAINST THE END OF THE STENT AND IT DISLODGED FROM WHERE IT WAS ORIGINALLY IMPLANTED. THE LEADING EDGE OF THE STENT WAS NOW IN THE DISTAL IVC EXTENDING INTO THE LCIV. A BALLOON WAS USED TO PULL THE STENT DOWN AND AN APPOSING STENT WAS PLACED FROM THE DISTAL IVC INTO THE RIGHT CIV AND THE STENT ON THE LEFT WAS EXTENDED INTO THE LEIV. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.