inforMED
MalfunctionHCG

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

Catalog 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 THUS, THE SUBJECT COIL WAS WITHDRAWN AND DISCARDED, THE PHYSICIAN COMPLETED THE PROCEDURE WITH OTHER DEVICES.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.