EMBOSHIELD EMBOLIC PROTECTION SYSTEM
Received Aug 2, 2006 · Event occurred Jun 30, 2006
Report 9616695-2006-00110 · MDR key 744871
Device
Generic name
Percutaneous Catheter
Manufacturer
Abbott Ireland Vascular DivisionModel number
NACatalog number
E6190
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Embolus
- Transient Ischemic Attack
- Shaking/Tremors
- Hospitalization required
Narrative
Description of Event or Problem
IN 2006, A PHYSICIAN SUCCESSFULLY DEPLOYED AN EMBOSHIELD INTO THE LEFT INTERNAL CAROTID ARTERY; PRE-STENT DILATATION WAS PERFORMED WITH ANOTHER BRAND OF BALLOON; THE XACT STENT WAS SUCCESSFULLY POSITIONED AND DEPLOYED; POST STENT DILATATION WAS NOT PERFORMED; THE EMBOSHIELD WAS SUCCESSFULLY RETRIEVED. IT WAS REPORTED THAT AFTER THE BALLOON INFLATION AND STENT DEPLOYMENT, THE PATIENT BEGAN SHAKING AND HAD SLURRED SPEECH THE HEAD CT SHOWED NO ACUTE SHE HEMORRHAGE. THE PATIENT WAS DIAGNOSED WITH LEFT SIDE TRANSIENT ISCHEMIC ATTACK DUE TO DECREASED PERFUSION FROM THE INFLATED BALLOON. THE DATE OF RESOLUTION WAS 2006. THE PATIENT STAYED ONE EXTRA DAY IN THE HOSPITAL AND WAS DISCHARGED TO HOME ON THE SAME DAY.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFORMATION. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE.