TARGET 360 ULTRA 3MM X 10CM
Received May 22, 2026 · Event occurred Apr 30, 2026
Report 3008881809-2026-00328 · MDR key 25256896
Device
Generic name
Device, Neurovascular Embolization
Manufacturer
Stryker Neurovascular CorkCatalog number
M0035423100
Lot number
24310842
Product problems
- Expulsion
Patient
55 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS INDICATED FOR STENT ASSISTED COIL EMBOLIZATION PROCEDURE. HOWEVER, WHILE FILING THE ANEURYSM WITH NON-STRYKER COIL, THE COIL PERFORATED THE ANEURYSM AND CAUSED BLEEDING. THE PHYSICIAN ADVANCED THE SUBJECT COIL AND ATTEMPTED TO EMBOLIZE THE ANEURYSM, BUT THE SUBJECT COIL CONTINUED TO PROTRUDE THROUGH THE ANEURYSM RUPTURE AND COULD NOT EFFECTIVELY SEAL THE RUPTURE. THE PHYSICIAN THEN FILLED ANOTHER FEW COILS AND REATTEMPTED WITH THE SUBJECT COIL, HOWEVER THIS TIME THE SATISFACTORY PACKING EFFECT WAS NOT ACHIEVED. THUS, THE SUBJECT COIL WAS WITHDRAWN AND DISCARDED, THE PHYSICIAN COMPLETED THE PROCEDURE WITH OTHER DEVICES. NO FURTHER INFORMATION AVAILABLE.