EN SNARE®

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING COIL EMBOLIZATION PROCEDURE FOR ARTERIAL ANEURYSM TO RETRIEVE A DEVIATED COIL, THE LOOP REGION OF THE SNARE DETACHED WITHIN THE PATIENT'S BODY. IT GOT STUCK AND THE SNARE PORTION GOT DETACHED. BOTH THE DISCONNECTED LOOP AND THE DEVIANT COIL WERE COVERED WITH A STENT, AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL ADVERSE EVENT HAS NOT BEEN REPORTED. THE STENT WAS LVIS INTRALUMINAL SUPPORT DEVICE FROM TERUMO, AND IT WAS DECIDED TO BE PLACED FOR BAILING-OUT DURING THE PROCEDURE WITH OR WITHOUT DETACHMENT OF THE SNARE. THE COIL ATTEMPTED TO BE RETRIEVED WITH THE SNARE WAS OPTIMA FROM CENTURY MEDICAL.

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.