AURYON ATHERECTOMY CATHETER

Additional Manufacturer Narrative

AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CATHETER USED DURING THIS PROCEDURE WAS NOT RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF CATHETER OR LASER SYSTEM MALFUNCTION, JUST AN ANTICIPATED PROCEDURAL COMPLICATION OF DISSECTION. FOLLOWING AURYON ATHERECTOMY AND BALLOON ANGIOPLASTY, A FLOW-LIMITING NHLBI TYPE C DISSECTION OF THE P2 POPLITEAL ARTERY WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH STENT PLACEMENT. LASER UNIT EXL075 WAS USED DURING THE PROCEDURE, AND NO LASER SYSTEM OR DEVICE MALFUNCTIONS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATOR ASSESSMENT, THE MOST PROBABLE ROOT CAUSE IS PROCEDURE-RELATED VESSEL INJURY ASSOCIATED WITH ENDOVASCULAR TREATMENT OF PAD. A CONTRIBUTION FROM THE AURYON LASER SYSTEM IS NOT SUPPORTED BY THE AVAILABLE EVIDENCE. THE DHR WAS REVIEWED FOR THE CATHETER LOT NUMBER. THE REVIEW CONFIRMED THAT THE LOT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS, E.G., NO MANUFACTURING NON-CONFORMANCE REPORTS WERE ISSUED. LABELING REVIEW: INSTRUCTIONS FOR USE (IFU0110 / IFU0120) ARE PROVIDED WITH THE CATHETER DEVICE AND CONTAIN THE FOLLOWING STATEMENTS: WARNINGS PAY CAREFUL ATTENTION WHILE USING THE CATHETER, AVOID EXCESSIVE FORCE, AND BE ON ALERT FOR ANY POTENTIAL DAMAGE. INADVERTENT MOVEMENT OF THE CATHETER MAY RESULT IN PATIENT INJURY. PROXIMAL VESSEL DIAMETER MUST BE []150% OF THE OUTER DIAMETER OF THE AURYON CATHETER. ALWAYS USE FLUOROSCOPIC SURVEILLANCE WHEN ADVANCING THE AURYON CATHETER INSIDE THE PATIENT VASCULATURE TO AVOID MISPLACEMENT, DISSECTION, OR PERFORATION. POTENTIAL COMPLICATIONS: AS WITH THE USE OF SIMILAR THERAPIES, THE FOLLOWING POTENTIAL COMPLICATIONS MAY OCCUR WITH THE USE OF THIS CATHETER, ACCESSORIES, AND ADJUNCTIVE THERAPIES (E.G., BALLOON, STENT, ETC.). THESE COMPLICATIONS MAY INCLUDE BUT ARE NOT LIMITED TO: PROCEDURAL COMPLICATIONS: PERFORATION. AURYON CATHETER INSERTION OVER THE WIRE UNTIL LASER ACTIVATION: YOU MAY USE ANY OTHER GW TO CROSS THE LESION, BUT THE FINAL GW THAT AURYON CATHETERS WILL TRACK OVER SHOULD BE 300CM 0.014", AND PREFERABLY STIFF GWS. ONCE THIS GW IS ANGIOGRAPHICALLY VERIFIED TO CROSS THE LESION IN THE VESSEL'S LUMEN, IT IS READY FOR AURYON CATHETER INSERTION OVER THE WIRE. ADVANCEMENT OF AURYON CATHETER THROUGH THE LESION: A) DO NOT TO EXCEED 10 SECONDS OF CONTINUOUS LASING AT THE SAME LOCATION. IF YOU EXPERIENCE ANY DIFFICULTY ADVANCING THE AURYON CATHETER, IMMEDIATELY START A 10-SECONDS SELF-COUNT-DOWN. SELF-COUNT-DOWN SHOULD START THE MOMENT YOU EXPERIENCE NON-ADVANCEMENT OF THE AURYON CATHETER. WHEN ADVANCEMENT RESUMES, STOP THE SELF-COUNT-DOWN AND RESUME IT IF ADDITIONAL DIFFICULTY ADVANCING THE AURYON CATHETER IS EXPERIENCED. B) IF THE AURYON CATHETER CANNOT BE ADVANCED BY THE 10TH SECOND OF LASER ACTIVATION, RELEASE THE FOOTSWITCH TO STOP THE LASER, RETRACT THE CATHETER APPROXIMATELY 3-4 MM, AND TRY TO ADVANCE AGAIN WHILE ROTATING THE CATHETER SHAFT APPROXIMATELY 90 DEGREES TO EITHER SIDE, WHILE RESUMING THE 10-SECOND SELF-COUNT-DOWN. C) IF THE AURYON CATHETER STILL CANNOT BE ADVANCED WITH THE ABOVE-MENTIONED ROTATION MANIPULATION FOR THE ADDITIONAL 10-SECONDS, IMMEDIATELY STOP THE LASER ACTIVITY BY RELEASING THE FOOTSWITCH. D) ASK THE LASER OPERATOR TO RAISE THE FLUENCE TO THE 60MJ/MM2. E) ACTIVATE THE LASER AND TRY AGAIN TO ADVANCE THE AURYON CATHETER THROUGH THE LESION. F) IF THE AURYON CATHETER CANNOT BE ADVANCED, RESUME THE 10-SECOND SELF-COUNT-DOWN. G) IF THE AURYON CATHETER CANNOT BE ADVANCED IN THIS ATTEMPT, STOP THE LASER ACTIVITY, WITHDRAW THE AURYON CATHETER AND USE A NEW CATHETER. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

Description of Event or Problem

AMBITION BTK REGISTRY SUBJECT:(B)(6) A FLOW-LIMITING NHLBI TYPE C DISSECTION OF THE P2 POPLITEAL ARTERY OCCURRED AFTER ATHERECTOMY AND ANGIOPLASTY. IT WAS SUCCESSFULLY TREATED WITH STENT PLACEMENT, RESULTING IN COMPLETE FLOW RESTORATION.