PRECISE PRO RX
Received Jul 13, 2026 · Event occurred Jun 10, 2026
Report 9616099-2026-00968 · MDR key 25796985
Device
Product problems
- Difficult to Remove
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, THE SHAFT OF AN 8 MM X 40 MM PRECISE PRO CAROTID SELF-EXPANDING STENT (SES) DELIVERY SYSTEM COULD NOT BE COMPLETELY WITHDRAWN AFTER DEPLOYMENT OVER A NON-CORDIS EMBOLIC PROTECTION DEVICE. THE PRECISE PRO DELIVERY SYSTEM COULD BE PULLED UNTIL THE MAIN BODY CAME OUTSIDE THE BODY, BUT COMPLETE WITHDRAWAL WAS IMPOSSIBLE. BECAUSE IT COULD NOT BE WITHDRAWN, A RETRIEVAL DEVICE FOR THE NON-CORDIS EMBOLIC PROTECTION DEVICE COULD NOT BE INSERTED. THE DELIVERY SYSTEM WAS ABLE TO BE PUSHED, AND AS A COUNTERMEASURE, THE OUTER MEMBER WAS ADVANCED THROUGH THE STENT AND AN ATTEMPT WAS MADE TO RETRIEVE THE NON-CORDIS PROTECTION DEVICE, BUT THIS COULD NOT BE DONE. RAISING A NON-CORDIS 8F BALLOON GUIDE CATHETER AND ATTEMPTING RETRIEVAL WAS ALSO UNSUCCESSFUL BECAUSE THE STENOTIC SEGMENT COULD NOT BE CROSSED. A NEW UNKNOWN GUIDING CATHETER WAS INSERTED FROM THE CONTRALATERAL FEMORAL APPROACH AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED ON THE LESION WITH A BALLOON. AFTER PTA, THE GUIDING CATHETER WAS ADVANCED, THE NON-CORDIS PROTECTION DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS USED TO TREAT RIGHT CAROTID ARTERY STENOSIS VIA A RIGHT FEMORAL APPROACH. AFTER PLACEMENT OF THE PROTECTION DEVICE ACCORDING TO THE USUAL PROCEDURE, THE PRECISE PRO STENT WAS DEPLOYED. THERE WAS NO PROBLEM WITH DEPLOYMENT ITSELF. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE USER MAINTAINED A FIXED INNER SHAFT POSITION DURING DEPLOYMENT, AND THERE WAS NO STENOTIC SEGMENT WITHIN THE STENT AFTER DEPLOYMENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.