inforMED
InjuryPUU

COMANECI 17

Received Mar 27, 2023 · Event occurred Mar 10, 2023

Report 3015531723-2023-00005 · MDR key 16618079

Device

Generic name

Comaneci 17

Manufacturer

Rapid Medical Ltd.

Model number

ANPP7199

Catalog number

ANPP7199

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

61 YR · Female

  • Aneurysm
  • Aneurysm

Narrative

Description of Event or Problem

COMANECI 17 WAS DEPLOYED ACROSS THE NECK OF THE BASILAR ANEURYSM. 5 TARGET COILS WERE DETACHED. UPON DETACHMENT OF THE FINAL COIL, IT WAS DISCOVERED A COIL WAS ENTANGLED WITHIN THE MESH OF THE COMANECI 17. THE PHYSICIAN REDUCED AND EXPANDED COMANECI 17 BUT WAS UNABLE TO SEPARATE THE COIL FROM THE COMANECI 17. THE PHYSICIAN ULTIMATELY ADVANCED HIS BENCHMARK TO THE COMANECI 17 AND PULLED IT ALONG WITH THE COIL OUT OF THE BODY. A LOOP OF ANOTHER COIL WAS THEN IN THE PCA AND BASILAR. THE PHYSICIAN DEPLOYED TWO ATLAS STENTS TO TACK DOWN THE COIL LOOPS AND THEN THE PROCEDURE ENDED.