VIPERWIRE

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT NON-TORTUOUS, 50% STENOSED LESION IN ANTERIOR TIBIAL ARTERY (AT) THROUGH COMMON FEMORAL ACCESS WITH A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). THE LEG WAS AMPUTATED AND THE WIRE WOULD NOT GO MORE DISTAL. THE VESSEL WAS PRIMARILY WIRED WITH AN UNSPECIFIED WIRE WHICH WAS EXCHANGED FOR A VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. THERE WAS NO WIRE BIAS. THERE WAS EXTREME DIFFICULTY WIRING AND DELIVERING ALL OTHER DEVICES. FOLLOWING 3 PROXIMAL-TO-DISTAL TREATMENTS THE OAD CROWN TANGLED THE VIPERWIRE TIP WHICH IS BELIEVED TO HAVE CAUSED THE TIP TO FRACTURE. THE PHYSICIAN WAS INSTRUCTED TO NOT GET THAT CLOSE TO THE TIP. THE CROWN DID NOT JUMP PRIOR TO THE FRACTURE. THE OAD WAS REMOVED AND THE 4CM-TIP WAS SNARED. THE PROCEDURE CONCLUDED SHORTLY AFTER THE FRAGMENT RETRIEVAL. IN THE PHYSICIAN¿S OPINION THE OAD CAUSED THE FRACTURE. THE PHYSICIAN DOES NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES. NO ADDITIONAL INFORMATION WAS PROVIDED.