MalfunctionHJE
NEUROFORM2 TREO MICRODELIVERY STENT SYSTEM
Received May 11, 2005 · Event occurred Apr 27, 2005
Report 6000078-2005-00074 · MDR key 603460
Device
Generic name
Intravascular Stent
Manufacturer
Boston Scientific Corp, Neurovascular DivModel number
*Catalog number
S345015
Lot number
MAR04103U
Product problems
- Device remains implanted
- Failure to Advance
Patient
*
- Surgical procedure aborted/stopped
Narrative
Description of Event or Problem
DURING AN EVENT THE NEUROFORM2 TREO MICRODELIVERY STENT SYSTEM WOULD NOT CROSS THE LESION, AND UPON WITHDRAWAL OF THE SYSTEM, THE STENT DEPLOYED. LEFT THE STENT IMPLANTED AND STOPPED THE PROCEDURE. THE PT WAS REPORTED TO BE DOING GOOD.