TARGET 360 NANO 3MM X 4CM
Received Jun 30, 2026 · Event occurred Jun 9, 2026
Report 3008881809-2026-00412 · MDR key 25669783
Device
Generic name
Device, Neurovascular Embolization
Manufacturer
Stryker Neurovascular CorkCatalog number
M0035443040
Lot number
25816291
Product problems
- Fracture
- Expulsion
Patient
57 YR · Female
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DETACH THE SUBJECT COIL, BUT THE SUBJECT COIL FAILED TO DETACH. FORCEFUL TRACTION APPLIED TO SUBJECT COIL DELIVERY WIRE, RESULTED IN BREAKAGE AT THE DISTAL SEGMENT OF THE DELIVERY WIRE. THE DETACHED DISTAL SEGMENT COULD NOT BE RETRIEVED. FOLLOW-UP ANGIOGRAPHY REVEALED SUBJECT COIL PROTRUSION, AND A RESCUE STENT WAS PLACED TO MANAGE THIS COMPLICATION. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.