inforMED
InjuryPUU

COMANECI EMBOLIZATION ASSIST DEVICE

Received Apr 24, 2023

Report 3015531723-2023-00007 · MDR key 16794565

Device

Generic name

Comaneci

Manufacturer

Rapid Medical Ltd.

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

70 YR · Unknown

  • Aneurysm
  • Aneurysm

Narrative

Description of Event or Problem

RAPID MEDICAL LITERATURE REVIEW FOUND A REPORT OF COIL ENTANGLEMENT WITH THE COMANECI EMBOLIZATION ASSIST DEVICE (SIOUTAS GS, SALEM MM, BURKHARDT J, ET AL COMANECI-ASSISTED COILING OF A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM: AN UNUSUAL CASE OF COIL RETENTION JOURNAL OF NEUROINTERVENTIONAL SURGERY PUBLISHED ONLINE FIRST: 04 APRIL 2023). THE PURPOSE OF THIS ARTICLE WAS TO PRESENT A CASE OF COILING A 5MM RIGHT POSTERIOR COMMUNICATING ARTERY RUPTURED ANEURYSM USING COMANECI AS AN ASSIST DEVICE IN A 70-YEAR-OLD PATIENT WHO PRESENTED WITH SUBARACHNOID HEMORRHAGE. DURING THE PROCEDURE, THE FIRST COIL WAS PLACED PROPERLY. HOWEVER, AFTER DETACHMENT OF THE SECOND COIL, PARTIAL COLLAPSE OF THE COMANECI DEVICE SHOWED A COIL LOOP THAT WAS ADHERENT, CONSEQUENTLY, THE COMANECI WAS RETRIEVED WITH THE ADHERENT COIL WITH NO SEQUELAES. SINCE THE SUBJECT ANEURYSM WAS PARTIALLY OCCLUDED, A 4X12 MM PIPELINE EMBOLIZATION DEVICE WAS PLACED ON POST BLEEDING DAY 19 WITH NO COMPLICATIONS. ACCORDING TO THE AUTHOR, COIL ENTANGLEMENT WITH THE COMANECI DEVICE IS RARE BUT POSSIBLE. THEREFORE, IT SHOULD BE IMMEDIATELY IDENTIFIED DURING PROCEDURE TO PREVENT FURTHER COMPLICATIONS. IT IS RECOMMENDED TO MAINTAIN A WORKING ANGLE THAT SHOWS THE BOUNDARY BETWEEN THE COIL AND THE DEVICE AT THE NECK OF THE ANEURYSM AND TO DEFLATE THE DEVICE BEFORE DETACHING EACH COIL, AS RECOMMENDED IN THE DFU.