AURYON¿ ATHERECTOMY SYSTEM
Received Jul 2, 2026 · Event occurred Jun 8, 2026
Report 1319211-2026-10026 · MDR key 25689557
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Embolism/Embolus
Narrative
Additional Manufacturer Narrative
THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).
Description of Event or Problem
DR. (B)(6) REPORTED A PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT 2 DAYS POST PROCEDURE WITH NO FLOW. HE STATED THE DEVICE CAUSED EMBOLIZATION AND THAT THE ARTERIES ARE FULL OF CLOT. THE PATIENT HAD TO UNDERGO AKA (ABOVE THE KNEE AMPUTATION). DR. (B)(6) STATES THIS HAPPENED AFTER HIS LASER WAS UPGRADED TO THE 8.4 SOFTWARE AND CONTINUED WITH THE 8.5. SOFTWARE.