WALLSTENT ENDOPROSTHESIS

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE PRODUCT STATUS AND ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

Description of Event or Problem

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AFTER ANGIOGRAPHY, A SIGNIFICANT STENOSIS WAS IDENTIFIED IN THE RIGHT SUBCLAVIAN AREA. A 14 X 60 / 9F UNI PLUS 75 CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED THROUGH A 10F SHEATH TO THE LESION. DURING DEPLOYMENT, RESISTANCE WAS ENCOUNTERED AND PROPER DEPLOYMENT WAS NOT ACHIEVED. THE DEVICE WAS WITHDRAWN AND TESTED OUTSIDE THE BODY, WHERE RESISTANCE DURING DEPLOYMENT WAS OBSERVED. THE DEVICE WAS CONSIDERED DAMAGED. BALLOON PREDILATION WAS PERFORMED, FOLLOWED BY BALLOON DILATION ALONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS STABLE POST-PROCEDURE.